Student Projects
Quantitative Research Proposal

A Comparison of Kangaroo Care Versus Traditional Nursery Care in Healthy, Term Neonates

Janice Collins

Abstract
Kangaroo care is also known as kangaroo mother care, kangaroo baby care, and skin-to-skin care. Although the name varies based upon the geographic area, the concept is that of holding an infant, naked except for a diaper and hat, against the bare chest of an adult for the purpose of providing the infant with a neutral thermal environment, nurturing touch and enhanced opportunity to breast-feed. Most often this adult is the mother or father, but other adults may also provide kangaroo care. Once the infant is positioned upon the caregiver's chest, a light cotton blanket is folded into fourths and then applied over the infant's back and extremities. The theory underlying the effects of kangaroo care, is that human infants, like many mammalian infants, are physiologically programmed to achieve and maintain stabilization based upon sensory input derived from continuous physical contact with caregivers. Research has revealed that in premature or stressed infants, metabolic status and temperature stability are enhance both during and after kangaroo care (Bauer, Sontheimer, Fischer, Linderkamp, 1996; Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote, Rey, 1999) Although numerous studies have explored the value of kangaroo care for premature or stressed newborns, the literature describing the effects of kangaroo care for healthy, full-term, newborns is scarce.

The current predominant model of neonatal delivery room stabilization involves placing the infant in an open warmer immediately after delivery. By its very design, this practice immediately separates the mother and infant during a crucial period of extrauterine adaptation, and may be a venue for delayed neonatal physiological adaptation, reduced breast-feeding and impaired maternal infant bonding (Ludington-Hoe, Nguyen, Swinth and Satyshur, 2000). Kangaroo care represents a delivery room stabilization method superior to traditional methods in terms of cost effectiveness, improved neonatal physiological outcomes, increased breast-feeding initiation, and enhanced maternal- infant bonding (Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote and Rey, 1999). The goal of this study is to explore the use of kangaroo care as a stabilization method for healthy, term neonates in the delivery room. This study will compare the variables of abdomen and toe temperatures, together with the oxygen saturation status of infants who receive kangaroo care at delivery, versus those infants receiving traditional nursery care at delivery.
Chapter One: Introduction to the Problem


Introduction to the problem
Kangaroo care originated in Bogota, Columbia in the 1970s as a method of caring for premature infants in the absence of incubators and other technical equipment (Bauer, Sontheimer, Fischer, Linderkamp, 1996). Kangaroo care is the holding of an infant, naked except for a diaper and hat, upon the bare chest of an adult - usually the mother. Once positioned upon the chest of the adult, the infant's back is then covered with a single cotton blanket folded into fourths. Since its inception, kangaroo care has been widely used and widely studied in the premature and stressed infant populations. Research has demonstrated that for these infants, kangaroo care decreases episodes of apnea and bradycardia, and overall energy expenditures while simultaneously enhancing oxygenation status, and periods of quiet sleep (Bauer, Sontheimer, Fischer, Linderkamp, 1996) which leads to enhanced newborn growth and development. Kangaroo care has been demonstrated to not only comfort infants and mothers, but also to enhance their long-term relationships to each other, while simultaneously strengthening the integrity of the entire family bond (Bauer, Sontheimer, Fischer, Linderkamp, 1996; Feldman, Weller, Sirota, Eidelman, 2003). In undeveloped countries, kangaroo care is used extensively not only as a stabilization method, but also as a method of providing a continuous neutral thermal environment for fatigued and premature infants (Bauer, Sontheimer, Fischer, Linderkamp, 1996; Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote,Rey, 1999). Yet despite the demonstrated benefits of kangaroo care to the stressed and premature infant populations, the benefits of kangaroo care for healthy, term neonates have not been investigated.

Phenomenon of Interest

Despite the many measurable advantages to mothers and infants of immediate skin-to-skin contact soon after delivery, the American model of delivery room care remains a technologically focused event. Infants are separated from their mothers within moments of birth and are placed into radiant warming units for immediate assessment by medical personnel. Delays in an infant's ability to stabilize require staff to remain at the bedside to continuously monitor the infant and intervene as necessary until stabilization is achieved. Often infants continue to remain isolated and removed from their mothers, in radiant warmers, while nonessential stabilization interventions like weights and measurements, medication administration, and even baths are performed for caregiver convenience. The rapid environmental change from intrauterine to extrauterine conditions causes some infants to rapidly chill, thus necessitating even more prolonged separations in "the warmer". Roughly 3.9 million infants are born in hospitals each year via normal spontaneous vaginal delivery. Traditional neonatal stabilization is usually accomplished with a team of caregivers who have often temporarily reorganized other care giving duties in order to assist in the stabilization process. It is possible that kangaroo care for healthy, full term neonates could facilitate newborn transition and diminish the required medical personnel, drugs, testing, formula supplementation and equipment currently utilized to accomplish the task.

Significance of the issue to Midwifery/Women's Health

In recent years, the American health care system has been in crisis. Although this country's health care expenses continue to escalate each year, Americans themselves are not measurable healthier. The tide of American consciousness is increasingly turning toward wellness and improved health as indicators of satisfying health care services. Kangaroo care at delivery is a very low-technology based, highly humanistic approach to care for healthy, full-term newborns. This type of newborn stabilization has been practiced by midwives for years, yet has not been adopted as standard by the main stream medical community. Midwives are ideally placed to model this form of care with all their client families, and in so doing, to help make this form of newborn stabilization a recognized industry standard. The current American standard of newborn stabilization is technology laden, not evidenced based, and is usually perpetuated for caregiver convenience. Research is needed to clearly document the measurable benefits to healthy, full-term newborns of kangaroo care versus traditional, technology based stabilization techniques.

This study will explore selected neonatal physiological outcomes of kangaroo care when compared to standard nursery care. This information will assist midwives in making evidence-based clinical decisions regarding which method on newborn stabilization to employ in the delivery room.

Study Purpose

The purpose of this research is to determine which method is newborn stabilization in the delivery room is superior, standard nursery care or kangaroo care. This research will take into consideration breast-feeding promotion and infant state.

Type of Study

This quantitative research study proposal will be designed to collect data in order to identify the optimal newborn stabilization technique. Abdomen and toe temperatures, together with the oxygenation status of healthy, full-term neonates receiving kangaroo care as a method of delivery room stabilization will be compared to those same variable in neonates being stabilized utilizing traditional nursery care methods. A descriptive, experimental design will be used since the purpose of this study is to determine if kangaroo care is less effective, equally effective, or superior to traditional nursery care as a method of delivery room stabilization for healthy, full-term neonates.

Study Question

1. How does kangaroo care compare with traditional nursery care as a delivery room stabilization technique for healthy, term-neonates?

Theoretical and Operation Definition of Terms

Independent Variables:

Kangaroo Care: Positioning of a neonate, (naked except for a diaper and hat), prone and upright, between the breasts or upon the bare breast of the mother and underneath her clothing. A cotton blanket, folded into fourths may be placed over the infant's back. (Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote and Rey, 1999).

Traditional Nursery Care: Conceptual definition: an inherited, established, or customary pattern of care, thought, action, belief or customs handed down from one generation to another. ( Websters, 1996) The immediate isolation of the neonate into a pre-warmed radiant warmer until rectal temps between 36.50 and 37.00 C are maintained. (Seidel, Rosenstein and Pathak, 2001)

Dependent Variables:

Abdominal Temperature: Conceptual definition: Abdomen is that part of the body between the thorax and the pelvis. Temperature is the degree of hotness or coldness that is natural to the body that is measured on a definite scale; i.e. a thermometer. (Websters, 1996)
Toe Temperature: Conceptual definition: Toe is a terminal digit of the foot. Temperature is the degree of hotness or coldness that is natural to the body that is measured on a definite scale; i.e. a thermometer. ( Websters, 1996)

Oxygen Saturation: Conceptual definition: A measurement of the amount of O2 dissolved in the blood. (Tortora and Grabowski, 2003)

Assumptions and Philosophical Approach

Kangaroo care is a stabilization technique that is in keeping with the midwifery philosophy of nonintervention while supporting the natural adaptive processes of the mother and infant. Kangaroo care places respect for, and support of the family at the center of the delivery room experience rather than disrupting those processes for care giver convenience. Kangaroo care at delivery offers a delivery room stabilization technique that is equal to and possibly superior to current, traditional nursery care.

Study Limitations

This proposed study will be to compare kangaroo care as a method of delivery room stabilization for healthy, term neonates to traditional nursery care for that same population. The accuracy of temperature and oxygenation readings will depend upon the skill of the persons applying the equipment and upon the anatomy of the test subject. There will be several providers applying measurement equipment to infants of varying anatomy. In addition, there will be several clinicians and data collectors. Individual variations may occur despite attempts to achieve high interrater reliability.
Chapter 2: Review of Literature & Conceptual Framework

Hospital delivery room stabilization is currently a technologically focused event in which the infant is immediately separated from the mother and placed in a radiant warmer. While this maneuver enhances access of medical personnel to the infant, its physiological benefit to neonates has been called into question. Rosenberg (2002) reminds us of the many physiological tasks the neonate must master in the first moments of extrauterine life: "thermoregulation, metabolic homeostasis, and respiratory gas exchange, as well as undergo the conversion from fetal to postnatal circulation pathways". We are further reminded by Rosenberg (2002) that the neonatal period is "marked by the highest mortality rate in all of childhood". This is a period requiring heightened care giver vigilance and careful adherence to the midwifery principles of watchful waiting, and while supporting the natural events of neonatal extrauterine transition.

Review of the Literature.

A literature search was conducted utilizing the PubMed and Medline search engines. Much of the available research conducted in the United States and Europe has focused on the care of premature and stressed infants. One research article which relates specifically to this author's topic of inquiry appeared in a 1998 edition of Anales Espanoles de Pediatria. Although this author endeavored to obtain a copy of this research, it was unavailable from any of the 15 university libraries in the United States which carried the journal, and therefore could not be included in this work.

Studies describing the physiological effects of kangaroo care.

Bauer, Sontheimer, Fischer and Linderkamp (1996) studied the association between kangaroo holding by parents and metabolic instability in very low birth weight premature infants. A study was conducted on 11 infants whose gestational ages ranged between 28 to 32 weeks, with birth weights between 560 to 1390 gm and postnatal ages from 8 to 48 days. All of the infants were being treated with theophylline for apnea, yet all were also breathing room air without supplemental oxygen. Since premature infants' carbon dioxide production and oxygen consumption are strongly influenced by feedings, each measurement period (before, during, and after kangaroo care) began 60 minutes after feeding and lasted 60 minutes. The first 15 minutes of each study-hour were omitted in an attempt to only study infants in steady-state conditions. The many variables examined in this study included continuous, sophisticated electronic measurements of the infant's oxygen consumption, carbon dioxide production, energy expenditure, skin and rectal temperatures, heart and respiratory rates, arterial saturation, and behavioral states.

This study supports that paternal and maternal kangaroo care have no adverse effect on energy expenditure in neonates, and thus, should be promoted. In fact, a closer look at the data reveals that oxygen saturation increased from 96% before maternal kangaroo care to 97% during the measurement period and remained elevated for the entire hour afterward. Similarly, the oxygen saturation of infants held by their fathers rose from 96% to 98% and remained elevated for the following hour. The measurements of energy expenditure revealed a drop from 2.56 (calories/kg/hour) prior to kangaroo care to 2.39 (calories/kg/hour) during kangaroo care with either parent. Moreover, the post kangaroo energy expenditure levels remained lower, at 2.45 (calories/kg/hour) for the hour afterward. Skin and rectal temperatures remained fairly constant before, during and after parental kangaroo care.

Although the sample size is small, this is an extremely well-crafted study and the results are still meaningful. Smaller sample sizes are considered powerful in physiologic studies aimed at describing basic processes. It cannot be missed that this is a study conducted by neonatologists and created for an audience of peers. The intent and tone of the article seems to be that of persuading neonatal intensive care nurseries to allow parents to hold their babies since doing so won't actually cause the infants any harm. However, since the subjects of this research were very low birth weight infants, it would seem likely that the "before" kangaroo care measurements were taken while the infant was either in a warmer or an incubator. Therefore, one could conclude from this article that kangaroo care in fact improves the metabolic status of the infant. Not only do oxygen saturation and temperatures increase during kangaroo care and remain so for an hour afterward, but energy expenditures are simultaneously reduced and remain diminished. This study is particularly useful by virtue of the many variables assessed with sophisticated electronic equipment. It provides useful scientific data to encourage and empower caregivers to move babies out of warmers and incubators and back into their parent's arms.

A comparison of kangaroo care and incubators was made by Ludington-Hoe, Hguyen, Swinth and Satyshur (2000). A randomized clinical trial of 16 kangaroo care infants and 13 control infants measured infant abdominal and toe temperatures using a pretest-treatment-posttest design. The study was conducted over three consecutive inter feeding intervals of 2.5 to 3.0 hours each, over a 1 day period. The infants averaged from 26 to 35 weeks gestation and received constant incubator care except for those infants being kangaroo care tested. The variables assessed in this study were infant toe and abdominal temperatures, and maternal breast temperatures, which were recorded each minute. Control temperatures of incubator infants were displayed and recorded each minute. Incubator environmental temperatures were also recorded each minute.

This study demonstrated that maternal breast temperatures quickly reached the neutral thermal zone range required by their infant by the fifth minute of kangaroo care. Once infant abdominal temperatures reached 36.8 OC, the maternal breast temperatures only varied by 0.1 to 0.3 OC for the remainder of the kangaroo care period. Simultaneously, kangaroo care infants experienced increases in toe temperatures from 4.0 to 6.0 OC from pre-kangaroo care to kangaroo care, but these heat gains were reversed once the infants were returned to their incubators. It was additionally noted that maternal breast temperatures changed 4 times more frequently than did the incubators in the 3 hour kangaroo care period, and changed in 0.1OC increments. By contrast, the incubators did not change their environment's temperature so minutely and did not respond as rapidly to the infant's temperature.

This study suggests that maternal physiology is, by design, a more responsive and superior form of neonatal thermoregulation. Infants allowed kangaroo care were quickly provided with a neutral thermal mircro climate not only devoid of drafts and exquisitely sensitive to their changing thermal requirements, but also heat shielding. This work is powerfully crafted and served as a spring board for the design of this author's study. The calibration, testing, and utilization of physiological measurement instruments outlined by these authors provided a road map that this author utilized in the creation of the current study.

Kangaroo care as a rescue method of stabilization was explored by Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote and Rey (1999). The subjects of this study were six 34-36 week preterm neonates with 5-minute APGAR scores of 6 or more. Two of the infants had grunting respirations prior to the initiation of kangaroo care which resolved during the measurement period. Immediately after delivery, all 6 infants were positioned in continuous kangaroo care with their mothers and then monitored for 6 hours. Variables assessed and recorded each minute, were heart rate, respiratory rate, oxygen saturation, abdominal temperature, and behavioral state. Not only did all monitored variables remain within normal ranges during the period of assessment, but all the studied infants were fully breast-feeding within 24 hours after birth, and approved for discharge between 24 and 48 hours after birth. Although the sample size of this study is quite small, it should be noted that similar infants at the study site who received traditional nursery care, experienced lengthy hospital stays.

This is an extremely small and well crafted study in which two separate researchers simultaneously recorded information about either the mother or infant every minute for six hours. The researchers would switch their roles between documentation of either the mother or infant data every two hours. The use of the thermistor and pulse oximeters described in this study guided this author in the creation of the data collection format for this study.

A comparison study between the effects of kangaroo care versus conventional cuddling care was produced by Roberts, Paynter and McEwan (2000). Conventional cuddling care was described as infants dressed and swaddled in a light blanket, but did not define the dress of the adult care giver. The assumption is made that the adult was also dressed and that the study was conducted while the infant was held by the adult. Kangaroo care was described infants as dressed only in a diaper, "with the addition of a bonnet for smaller babies". The infants were positioned on their mother's "skin" and then covered with a light blanket "to ensure privacy". The details of kangaroo care duration and frequency are sketchy, but it appears that once subject infants were enrolled in the study, they received kangaroo care on a daily basis until discharge. The average length of study participation was roughly 47 days. Using an experimental design, the 30 mother-infant dyads were randomly assigned to the kangaroo care group or the cuddling care group. Males and females were evenly dispersed in both groups. All infants were born at 30 or more weeks gestation and had 5-minute APGAR scores of 5 or higher. Subjects were accepted into the study based upon the parents having a good understanding of English, being a local residents, preparation to spend a minimum of two hours a day for five days a week over a maximum of four weeks participating in the study, and lack of drug use in the mother. The test and control groups were not significantly different for mother's age, parity, gravidity, gestational age, type of delivery, Apgar ratings, gender of baby, baby's birth weight at the beginning of the study of time spent in kangaroo care of cuddling care. All subject infants were stable and on room air for at least 24 hours prior to the study. All infants were free of phototherapy for at least 24 hours prior to the study, and infants who had been resuscitated were excluded.

Infant temperatures were assessed prior to and upon completion of kangaroo and cuddling care. The authors note that at some point their study was reduced to only 20 dyads, and thus they describe their findings regarding the temperature comparisons as "not enough to analyze statistically". They note that for both groups, temperatures remained stable or rose by 0.2o-0.4oF (0.1o-0.2oC). The group mean temperature before either kangaroo care or cuddling care for both groups was 98.1o + 0.2oF (36.7o + 0.1oC) and after kangaroo care and cuddling care, it was 98.4o + 0.4oF (36.9o + 0.2oC). One weakness of this study is the failure to describe how long these sessions of kangaroo and cuddling care lasted. Similarly, there is no mention of the measurement of any temperature variabilities occurring during these times. The researchers describe their intention to measure pre-test and post-test temperatures only. Other variables observed were patterns of weight gain, length of stay and duration of breast feeding. No statistical differences between the two groups were revealed. It might be concluded from this study that the mere physical proximity of an infant to its mother can produce measurably improved neonatal outcomes.


Studies describing the neurological and developmental effects of kangaroo care.

Feldman and Eidelman (2003) conducted an extremely thorough and elegant study in which they concluded that kangaroo care accelerates autonomic and neurobehavioral maturation in preterm infants. This study examined 70 preterm infants who were matched for sex, birth weight, gestational age, medical risk and family demographics. Kangaroo care was provided to 35 infants for at least one hour per day for 14 consecutive days. The control group received routine nursery care which entailed incubators and thus precluded direct infant contact with caregivers. Once infants matured to 34 weeks gestation, they were removed from their incubators for feedings.

Infant state, as a measure of neurological tone, was assessed at 32 weeks gestational age during four consecutive hours. Infant state was divided into six categories: Quiet Sleep, Active Sleep, Sleep-Wake Transition, Unfocused Alertness, Alert Wakefulness, and Cry. Observations in 10-second epochs were entered into a computer program. At 37 weeks gestational age, the infants were examined with the Neonatal Behavioral Assessment Scale by a trained neonatologist. It was noted at this time that for the kangaroo care infants, quiet sleep increased, active sleep decreased, and periods of alert wakefulness increased (p=0.008). Kangaroo care infants spent more time in quiet sleep and alert wakefulness and less time in active sleep (p=0.006).

Vagal assessment was made by recording infant heart rates for approximately 10 minutes. There was no statistical difference between the two groups at 32 weeks gestational age before the initiation of kangaroo care. However at 37 weeks gestational age, the kangaroo care group demonstrated matured and increased vagal tone (p<0.001).

Neurologically, it was found that the range of states expressed by both groups was the same. However, habituation and orientation were improved after kangaroo care. The authors noted that all the neurological measures which improved after kangaroo care related to better infant orientation to the external environment. It is suggested that this is made possible by the infant's improved ability to regulate his/her internal state and that this mastery is facilitated by the mother's physical presence. Long after pregnancy ends, the mother's physiology continues to provide guidance and direction which facilitates neonatal adaptation to extrauterine life. A limitation of this study relates to it not being a prospective, randomized study. According to the authors, randomization was prohibited by their Institutional Review Board. Also, since the kangaroo care group and control groups were being managed by the same care providers, there existed within the study the possibility of selection biases. However, since physiological endpoints like vagal tone measurements are immune to biases, the validity of this study's findings do not seem questionable.

The lasting effects of kangaroo care on behavioral organization, development and temperament were investigated by Ohgi et al., 2002). This was a historical control study consisting of 26 kangaroo care infants and 27 control infants who received standard nursing care. The infants of both groups were assessed at 40 weeks postmenstrual age and at 6 and 12 months corrected ages. Kangaroo care was initiated at one day of age and lasted from 20 minutes to 2 hours, twice a day, almost everyday. By contrast, the control infants remained almost exclusively in their incubators for the first 2 to 3 weeks of life.

Assessment during the neonatal period revealed that orientation and state regulation were higher in the kangaroo care group. This was demonstrated by their enhanced ability to focus on visual and auditory stimuli, and also their ability to maintain stability in their state organization in the face of increasing levels of stimulation. Kangaroo care infants expressed a higher capacity for state regulation and better overall organization of the neurobehavioral system. The kangaroo care infants were judged calmer and easier to care for by their parents at 6 months of age. Assessment at 12 months corrected age using Bayley Scales showed that measures of both mental and psychomotor development were higher for the kangaroo care infants.

The results of this study would be more persuasive if the design had been prospective rather than historical. The authors admit that the control infants were not matched to the kangaroo care infants, so the question of validity in the findings is raised. However, the conclusions of this study do not differ for those reached by more rigorous scientific inquiries. If these conclusions are accurate, then routine neonatal intensive care which relegates premature infants to total isolation from human contact seems detrimental to neonatal development and well being and should thus only be reserved for episodes of extreme medical necessity rather than routine care. Similarly, it stands to reason that the current American model of standard nursery care which places normal newborns in isolation could be viewed not only as totally unnecessary, but also as quite possibly detrimental.

Studies describing the impact of kangaroo care upon family dynamics.

A study by Feldman, Weller, Sirota and Eidelman (2002) explored whether or not parent-infant and family relatedness are improved following the provision of mother-infant kangaroo care to premature infants in early life. Seventy-three kangaroo care premies were matched with controls to give a total sample size of 146 infants. The families of both groups were matched for maternal and paternal education, age, parity and maternal employment. This study was conducted in Israel and no other ethnic description was given other than to say that the two control and experimental groups were "matched for ethnicity". In the two groups, each mother was married to the infant's father, mothers were at least 20 years old, parents had completed high school, and families' socioeconomic status was considered middle class by Israeli standards. Families were matched for parity (first vs. later born), and twins and singletons were equally numbered in the two groups and matched separately for birth weight, gestational age, and medical risk. Kangaroo care was initiated as soon as the infants were medically stable and involved at least one hour a day of kangaroo care for at least 14 consecutive days.

The infants were assessed at 37 weeks gestational age, and again at 3 and 6 months corrected ages. At 37 weeks, the mothers and infants were videotaped in a free interaction for 10 minutes. At 3 months, trained observers visited the families' homes and spent approximately 1.5 hours with the mother and father present. The 6 month assessment measured development and was conducted in a laboratory. At every assessment point, the mothers completed self-report surveys.

The combined results of these serial assessments revealed that kangaroo care mothers looked more at their infant, touched the infant more frequently, showed a more positive affect, and were more adaptive to the infant's signals. Kangaroo mothers provided better and more adaptive home environments for their infants. Mothers who provided kangaroo care also reported less depressive symptoms and perceived the infant as more normal and rather than unlike a "normal", i.e. full-term, infant. This could possibly be linked to the determination that kangaroo care improved the motor and cognitive development of premature infants. Kangaroo care improves family functioning because mothers are more in tune with their infants and their infants are similarly more responsive and more developmentally mature. This positive interaction promotes the mother's sense of well being and further potentiates positive family functioning. This well crafted and extremely complex study yields a vast array of information about family dynamics and infant development. The authors conclude that kangaroo care not only provides immediate benefits to the newborn, but also has positive ramifications that extend to the entire family unit. This study was not a randomized clinical study, but rather a comparison between two matched groups. It is interesting that the authors note that the study could not be randomized because kangaroo care "is not an experimental technique but is considered to be a standard of care option, and thus randomization was precluded for ethical reasons". The study was made possible because the researchers had access to matched patient populations at two different hospitals who were instituting kangaroo care at different times.

In a similar study conducted by Feldman, Weller, Sirota and Eidelman (2003), they again describe the 73 matched pairs of kangaroo care and control infants. Again all subjects are described as being matched for gender, birth weight, gestational age and medical risk. The family groups are described as being middle class, and thus representing "the majority of young families in the Israeli population". The authors go on to specify matching of subject families for maternal and paternal age, education, parity (primiparous versus multiparous), and maternal employment (no, part-time, or full-time employment). It is again noted that the mothers were married to their babies' fathers, and that none smoked cigarettes or utilized drugs. The authors also describe the kangaroo and control groups as being simultaneously assessed at two different hospitals. Given all the similarities between this and the previously discussed study, it seems reasonable to assume the results described in this article, represent a teasing out of different data from the same, previously described experiment.

As in the previous study by these authors, the constructed variables and the measurement times are identical for both studies. The one unique variable discussed in this study was the idea that all the subject infants must be designated for enclosed incubators rather than open incubators during the 14 day testing period. The kangaroo care intervention was specifically targeted to a time period when the premature infants would otherwise be deprived of full maternal contact.

The authors found that the kangaroo care mothers demonstrated more sensitivity and less intrusion during interactions at 37 weeks gestational age, and 3 and 6 months corrected ages. Also, the level of dyadic reciprocity between mothers and infants was higher and the infants showed less negative emotionality during social play. The kangaroo care fathers were also more sensitive and less intrusive, with higher reciprocity and less negative infant emotionality displayed. Kangaroo care infants spent more time in focused gazing as compared to control infants.

During observed family interactions, kangaroo infants were often placed in "free" positions (in arms or on the floor), whereas control infants were usually placed in more constrained positions like car seats. Kangaroo care parents touched their infant and each other more, and spent less time out of each other's arms' reach, as compared with controls. A relationship was found between increased touching of kangaroo care fathers toward their infants. In turn, the wife's loving touch of her husband increased after kangaroo care. The kangaroo care provided to the infant seems to generate increased loving touch between all the family members. It seems that fathers are attracted to infants who are loved by their wives, and their wives are in turn more attracted to the fathers who love their infants. Touch, in effect, is contagious and possibly creates greater marital intimacy in the whole family context.

Studies describing barriers to kangaroo care.

Premature infants in neonatal intensive care units have been the primary focus of most kangaroo care research. Franck, Bernal, and Gale (2002) devised a national cross-sectional descriptive survey to explore current infant holding policies in American neonatal care units. A list of 400 regional, community, and intermediate-level neonatal units was identified from a 1997 list of such units provided by the National Association of Neonatal Nurses. Nurse managers or designated registered nurses were asked to respond to questions about specific practices and to submit copies of holding policies from their unit, if available. Of the 400 U.S. neonatal units who were polled, 215 returned surveys (53.75 percent) which were included for analysis. The regional-level institutions represented 22 percent of the responses given, the community-level neonatal units represented 45 percent, and the intermediate level hospitals represented 33 percent of the responses. Most surveys were completed by nurse managers (n = 159, 74 percent); the remainder were completed by advance practice nurses (n = 30, 14 percent) or staff nurses (n = 26, 12 percent). Nurses completing the survey had a mean of 16 + 6.09 (SD) years experience. Well newborn nurseries were excluded from study.


While most of the respondents regarded parental holding of infants beneficial to attachment, they did not rank increased lactation or improved parental self esteem as important variables. Not only did the survey reveal diminished care provider understanding of the physiological and developmental benefits of kangaroo care to the infants, many respondents determined kangaroo care a threat to infant stability. Seventeen percent of the respondents wrote that physician and nurse concerns limited parental holding, and several wanted to set time limits on parental holding. This study concluded that parental holding policies in U.S. neonatal units vary according to the care level provided by the institution, the perceived risks and benefits of kangaroo care and the opinions of medical personnel. This study seems like an appropriate initial step in exploring the holding policies of U.S. neonatal nurseries. However, it too, specifically excludes well newborns from its discussion of kangaroo care, which is the specific subject group of this study.

Another national descriptive survey focused on current practice, perceptions, knowledge and barriers to kangaroo care in the United States. Engler et al., (2002) developed Kangaroo Care Questionnaires for this study which were sent to the nurse managers of all hospitals in the United States that were identified as providing neonatal intensive care services (n = 1,133). Instructions were given for the questionnaires to be completed by the nurse most familiar with the practice of kangaroo care in that unit. A second questionnaire set was sent to nonrespondents. A response rate of 59 percent (n = 537) revealed that over eighty two percent of the respondents utilized kangaroo care in some form. The questionnaires explored who practices kangaroo care, current nurse knowledge regarding kangaroo care, barriers to kangaroo care and barriers to kangaroo care. These responses were measured against current, evidence based knowledge regarding kangaroo care. It was found that of the 82 percent of respondents who reported practicing kangaroo care, the mean knowledge score was 75 percent correct, indicating gaps in the nurses' knowledge. Also, staff were increasingly negative about kangaroo care the lower the acuity of the neonatal case load population and the lower the total number of infants cared for by the unit. Bigger nurseries with sicker babies were more comfortable with kangaroo care. Barriers were determined to be lack of staff education and training and an absence of written policies. In fact, it was noted that the practice of kangaroo care seemed to be more strongly influenced by nursing perceptions than by scientific evidence. Staff reluctance seemed particularly focused on the misconception that kangaroo care would require extra work on their part. On the contrary, kangaroo care may reduce workload by enhancing infant stability and sleep, and by involving parents in their infant's care.

Even after 30 years of scientific research has continually validated both the immediate and long term benefits of kangaroo care to infants and their families, caregiver suspicions still limits its use. One goal of this study is to provide even more evidence of the benefits of kangaroo care. Many of the current reasons for not using kangaroo care as a delivery room stabilization method for healthy, term neonates are echoed as constraints by these authors: lack of staff support and education, lack of evidenced based practice, misconception that kangaroo care increases care giver work load.

Conceptual Framework.

According to Morse and Field, (1995), "a theory is a systematic explanation of an event in which constructs and concepts are identified and relationships are proposed or predictions made". A theoretical framework is the road map for a scientific study. It defines what variables will be assessed and suggests a potential 'destination', that is to say, a predictable relationship between the variables in question. A conceptual framework allows the researcher to build upon an existing body or knowledge. A conceptual map is a diagrammatic representation of the relationship between the variables being studied. The conceptual framework guiding this study is the hypothesized relationship between kangaroo care as a stabilization technique for healthy, term neonates, and measurably improved physiological outcomes of neonatal abdomen and toe temperatures along with oxygenation status.

Kangaroo care for premature infants has been used successfully around the globe for the past 3 decades. Facilitation of bonding and promotion of breast feeding have long been accepted benefits. It has been demonstrated to improve immediate metabolic status, ( Bauer, Sontheimer, Fishcher and Linderkamp, 1996), and enhance thermoregulation with the possible consequence of increased liver perfusion and augmented gluconeogenesis, (Ludington-Hoe, Nguyen, Swinth and Satyshur, 2000). Kangaroo care has been demonstrated as an effective means of not only stabilizing stressed, birth-fatigued infants, and enhancing breast feeding, but also precipitating early hospital discharge (Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote and Rey, 1999). Kangaroo care has been shown to enhance vagal tone maturation and neurological development (Eidelman, 2003). Behavioral organization, neurological development and temperament have been found to be measurably greater than that of control infants at 1 year of age (Ohgi, Fukada, Moriuchi, Kusumoto, Akiyam, Nugent, Brazelton, Arisawa, Takahashi and Saitoh, 2002). Kangaroo care has been shown to improve maternal mood and enhance total family dynamics like, stress, touch, sensitivity and responsiveness (Feldman, Weller, Sirota and Eidelman, 2003, Feldman, Eidelman, Sirota and Weller, 2002)

Yet despite the many valid benefits of kangaroo care to infants and their families, its use for American premies remains limited due to care provider bias and misinformation (Roberts, Paynter and McEwan, 1999, Franck, Bernal and Gale, 2002). A review of the literature reveals that kangaroo care for healthy, term neonates has hardly been explored at all.

The initial period of transition to extrauterine life is one of the most perilous physiological events an infant must face. A review of the literature suggests that infants are not intended to negotiate this complex physiological event in physical isolation from their mothers. Maternal breast temperature is exquisitely responsive to the thermal needs of the neonate (Ludington-Hoe, Ngyuyen, Swinth and Satyshur, 2000) and is vastly more responsive than mechanical warmers. The mother's body is familiar to the infant and physical contact may reduce infant stress and is seen to diminish crying (Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote and Rey, 1999). Reduction of crying is linked to improved respiratory control and minimization of right-to-left foramen ovale shunting and hypoxemia (Ludington-Hoe, Anderson, Simpson, Hollingsead, Argote and Rey, 1999).

Premature infants who receive kangaroo care from their mothers demonstrate accelerated autonomic and neurobehavioral maturation (Feldman and Eidelman, 2003), better behavioral organization, development, and temperament, (Ohgi, Fukuda, Moriuchi, Kusumoto, Akiyama, Nugent, Brazelton, Arisawa, Takahashi and Saitoh, 2002), and enjoy enhanced family dynamics (Feldman, Weller, Sirota, Eidelman, 2003, Feldman, Eidelman, Sirota and Weller, 2002). Kangaroo care infants are compared to control infants who received standard nursing care in an incubator and effectively, in isolation. Currently delivery room stabilization techniques involve similar physical isolation of a neonate during a period of extreme physiological stress. It is reasonable to assume that healthy, full-term neonates will benefit measurably from kangaroo care.

Traditional delivery room nursing care is outlined by Seidel, Rosenstein and Pathak (2001) as a process in which "the baby should be nude under a warmer, and the Apgar 1-minute score should be determined." Since most infants born into either traditional hospital settings, birth centers or any out of hospital settings are not attended at delivery by medical doctors, it is interesting that they add: "If a pediatrician is not called to the delivery room, these observations become the responsibility of those in attendance, and the nursery examination should be performed as soon as possible." This model of delivery room care for infants was created with focus being on facilitation of the caregivers' ability to assess the infant rather than facilitation of the infant's ability to negotiate adaptation to extrauterine life.

The authors go on to outline in order the steps of care:
1. Rapid drying with prewarmed towel immediately after birth.
2. Covering the head with a cap.
3. Placing under radiant warmer set to maintain rectal temperature between 36.5 0 and 37.0 0 C.
4. Skin-to-skin contact with the mother may be substituted if infant and mother are stable.

It must be noted that according to this model of traditional delivery room stabilization, not only is skin-to-skin contact between mother and infant not considered a part of the infant stabilization process, but furthermore, the mother infant dyad can only earn skin-to-skin contact by virtue of the infant's ability to stabilize itself in total isolation within the radiant warmer.
Effects of Skin to Skin Contact or Kangaroo Care

Maternal/Family Effects of Kangaroo CareNewborn Effects of Kangaroo Care
  • Maternal breast temperature attains a neutral thermal range for her infant by the 5th minute of kangaroo care
  • Maternal/infant bonding is enhance
  • Maternal affect, touch and adaptation to infant cues enhanced
  • Maternal report of less depression 3 months post delivery
  • Maternal perception of infant as 'normal' (rather than abnormal; i.e. preterm)
  • Parents of kangaroo care infants more sensitive and proved a better home environment at 3 months post delivery
  • Kangaroo care mothers more sensitive to infants at 6 months post delivery
  • Kangaroo care parents more sensitive and less intrusive, family style more cohesive
  • Kangaroo care parents increased affectionate touch of each other
  • Spouses maintain closer proximity to each other and infant which enhances mutual gaze and touch during triadic play
  • Breast-feeding initiation rates are enhanced
  • Infant enjoys a neutral thermal micro climate that is free of drafts and exquisitely sensitive to his/her fluctuating temperature needs
  • Metabolic energy expenditures are reduced
  • Crying is reduced, which in turn promotes regular respirations and may minimize right-to-left foramen ovale shunting and hypoxemia
  • Kangaroo care infants show enhanced vagal tone at 32 and 37 weeks' gestational age
  • Infants show more alertness and less gaze aversion
  • Stability of infant behavioral state is enhanced
  • Improvement in state organization in terms of longer periods of quiet sleep and alert wakefulness, and shorter periods of active sleep
  • More mature neurodevelopmental profile, particularly habituation and orientation
  • Kangaroo care infants score higher on the Bayley mental Development Index and Psychomotor Index
  • Enhanced developmental outcome over the first year of life demonstrated by low birth weight infants after kangaroo care
  • Demonstration of less negative effect
  • Touched more frequently by parents
  • Maintained in closer proximity by parents

From the very first moments of life, neonates and mothers are programmed to function optimally when in physical proximity to each other. That early initiation of breast-feeding diminishes uterine bleeding is a time honored fact. That the same early breast feeding in turn enhances neonatal stabilization is also accepted. There now exists a growing body of research which demonstrates that the benefits to mothers and infants (and even their families) of early kangaroo care are broad and far reaching. Maternal well being is enhanced by increased maternal sensitivity to infant clues and simultaneous diminution of maternal depression. Total family interaction is enhanced, which further promotes maternal well being.

The immediate physiological status of infants is enhanced by kangaroo care. In addition, long term physiological benefits are suggested, together with enhanced behavioral development. Kangaroo care infants are kept in closer physical proximity by their parents and are touched more often. Their parents create more appropriate environments to further enhance their development. All of these many benefits to preterm or stressed infants are well researched, and yet documentation regarding the benefit of kangaroo care for healthy, term neonates is nonexistent. This study will explore the benefits of kangaroo care as a delivery room stabilization method for healthy, term neonates.


Key Concepts and Relationships:

Conceptual Map

Method of delivery room stabilization (Kangaroo Care versus Traditional Nursing Care)
Kangaroo Care ---(+)---> Abdominal Temperature + Toe Temperature + Oxygen Saturation
Traditional Nursing Care --->(+)--->Abdominal Temperature + Toe Temperature + Oxygen Saturation

KC = Kangaroo care
TNC = Traditional Nursing Care
AT = Abdominal Temperature
TT = Toe Temperature
OS = Oxygen Saturation
Chapter Three: Methodology

Research Design

This quantitative research proposal will collect data in order to demonstrate the effects of the use of kangaroo care as a method of delivery room stabilization for healthy, term neonates. Research has demonstrated that kangaroo care is an effective method for enhancing the metabolic status' of stressed and premature infants, as well as promoting recovery in birth fatigued infants. This researcher suggests that it also represents an ideal method of delivery room stabilization for healthy, term infants. This experimental study will compare the use of kangaroo care in the delivery room as a method of stabilization for healthy, full-term neonates versus current infant stabilization techniques on selected neonatal outcomes. This study will compare the physiological variables of abdomen and toe temperatures, together with the oxygenation saturation, of neonates receiving kangaroo care as a delivery stabilization method, versus the abdomen and toe temperatures, and oxygenation saturation of neonates receiving traditional nursery care. The goal of this inquiry is to determine if kangaroo care as a delivery room stabilization method is an equally effective method for facilitating neonatal extrauterine transition. Kangaroo care as a stabilization technique for healthy, term neonates is hypothesized to promote extrauterine adaptation.

This research design is expressed in the following design notation form:
R1.............X1...............O1 (group 1 is randomized to kangaroo care as a delivery room stabilization method)


R2.............X2..............O2 (group 2 is randomized to receive traditional nursery care at delivery)


R= randomization
X= care received at delivery
O= observations


Internal and External Validity

Internal validity is the extent to which it is possible to infer that the independent variable is truly influencing the dependent variable. (Polit, Beck and Hungler, 2001) This study is a post-test only control group design which is a strong experimental design with regard to internal validity and moderately strong with regard to external validity. The primary internal threat to validity is the maturation threat. The possibility exists that neonates are programmed for extrauterine adaptation, and that this process will be successfully negotiated regardless of the type of care they receive.

In this experiment, the researcher will manipulate the type of delivery room care provided to neonates as the independent variable, and then observes its effect on the dependent variables of abdominal and toe temperatures and oxygen saturation status. The control group and experimental group subjects will be randomly assigned. The opportunity of each subject to have an equal chance of being included in either group decreases systematic bias.

External validity refers to the ability of research findings to be applied to larger populations. (Polit, Beck and Hungler, 2001). The external validity of this study is quite strong since its dependent measures are the fundamental response of neonatal physiology to kangaroo care. One possible threat to the external validity of this study could be the setting, which will be entirely in a hospital. Although hospital temperatures are carefully monitored, they may be difficult to regulate, and there can be great temperature variability during seasonal changes. Other threats may be the variability of care provider knowledge and skill. Some providers may be more willing to initiate kangaroo care, while others may be reluctant due to a basic insecurity in dealing with newborns which is ameliorated by reliance upon monitoring equipment.

Sampling Methods

Site

A sample of 30 mother infant dyads (n=30 total) will be recruited from Memorial Health University Medical Center of Savannah, Georgia. Fifteen mother infant dyads will be recruited for the kangaroo care group and 15 dyads will be recruited for the control group. Since the dependent measures of interest in this study are physiological measures, it is felt that a total sample size of 30 represents a realistic sample goal, yet one which will yield meaningful results. Permission to undertake this research will be obtained from the Chief Executive Officer, the Medical Director, the Director of Neonatology, the Director of Nurseries, the Chief OB, the Labor and Delivery staff, and the Mother Baby staff of this facility. This researcher is a former staff RN of this facility and currently has clinical privileges which grant access to patients in the Labor and Delivery Unit.

Population of Interest

The target population of interest includes all mother baby dyads delivering via vaginal delivery between 38 and 42 weeks gestation.

Entry to site/access to population

The researcher is a SNM with current clinical privileges and access to the labor and delivery population and also their infants of Memorial Health University Medical Center. Formal access to the study population will have to be obtained.

Inclusion/Exclusion criteria

All women presenting to this facility in the study data collection time frame in normal, uncomplicated labor, between 38 and 42 weeks gestation, will be asked to participate. This convenience sampling technique will be inexpensive, accessible, and less time consuming than many other types of samples. Informed Consent (Appendix A) will be obtained upon admission to the Labor and Delivery unit and prior to inclusion in the study.

Only healthy, term neonates born via vaginal delivery will be included in the study. Those infants born with anomalies, or requiring resuscitation will be excluded.

Sampling methods

A convenience sample of pregnant women presenting in labor at 38 to 42 weeks gestation will be evaluated for appropriate inclusion into the study by the researcher. Convenience sampling is of value to this study because of the availability of subjects. The convenience sample is easily accessed which makes the research feasible and relatively inexpensive. The researcher will describe the sample obtained demographically and compare it to national and/or state data on childbearing women to determine how representative the sample is of the whole population. No attempts will be made to control or manipulate which subjects are included for study.

Ethical considerations

Permission and approval for this study will be sought from the IRB of Philadelphia University, and the clinical site to ensure that human subjects' rights are protected. The participants will be fully informed about this research and what it includes, and the benefits to hopefully be gained in enabling providers to develop protocols that enhance neonatal extrauterine adaptation. Due to the element of maternal undress in this study, privacy and confidentiality are additional ethical considerations. The subject's identifying information and the data forms will be coded for data entry. The codes will only be known to the researcher who will keep this information locked and secured until the study is complete. Once the study information is encoded and compiled, the identifying information will be destroyed. Furthermore, it will never be disclosed by the researcher in any manner. All qualifying women will be invited to participate in this study and to sign an informed consent (see Appendix A).

Data collection procedures

Timeframe

The current volume of women delivering term, healthy neonates at Memorial Health University Medical Center is approximately 200 per month. Considering the sample size of 30 needed for this study, the researcher anticipates approximately one month for completion of gathering the data. This is taking into consideration that not every woman presenting for delivering vaginally will consent to participate in this research. Furthermore, not every delivered infant will meet eligibility criteria for inclusion in this study.

Procedure

Kangaroo care will begin at the moment of delivery and will continue, uninterrupted for one hour post delivery. Only vaginal births will be included. Immediately after delivery, a servo probe to continuously assess neonatal abdominal temperature will be applied one cm below the right costal margin. An additional temperature probe will be affixed to the right great toe to continuously assess neonatal toe temperature. An oxygen saturation monitor probe will also be applied ventral surface of the left foot near the junction of the smallest toe to continuously assess neonatal oxygen saturation status. An observer will remain at the bedside throughout monitoring, but will interact with the mother-infant pair only minimally and as required. The observer will record infant abdomen and toe temperatures and oxygenation saturation every five minutes. The observer will also note infant state, such as sleeping or crying, and feeding state.

Infant abdomen and toe temperatures, and oxygenation saturation will be recorded in 5-minute increments. Nonessential nursing care of the neonate and mother will be delayed until completion of the first hour of life, at which time ophthalmic antibiotic may be applied to the infant's eyes. All other routine nursing care will be delayed until completion of the second hour of life. During the period of kangaroo care, the mother-infant pair will be minimally disturbed by nursing staff, and then only to perform essential care.

Traditional nursery care will also begin at the moment of delivery. No alterations will be made to delivery room stabilization and care procedures except for the addition of toe temperature monitoring and oxygen saturation monitoring. Abdominal temperature monitoring is already a standard component of traditional nursery care. Abdomen and toe temperatures, along with oxygen saturation readings will be recorded in 5 minute increments throughout the first two hours of life. As with the kangaroo care subjects, an observer will remain at the bedside throughout monitoring, but will interact with the mother-infant pair only minimally and as required, also noting infant behavior and feeding states.

Description of each instrument and its reliability and validity

Servo monitoring of neonatal abdominal temperatures is a recognized industry standard of neonatal care. Neonatal radiant warming equipment is serviced yearly and continuously maintained in proper working order by the Biomedical Department of the Memorial Health University Medical Center. All servo monitors will be calibrated in a water bath prior to the study. All temperature readings will be measured and recorded in Celsius. The normal temperature range for neonates during extrauterine transition is
36.5-37.5 C rectal and axillary and 36-36.5 degrees C for skin.

Toe temperatures will be measured by application of probes to a single great neonatal toe.

Oxygenation saturation will be measured by application of a monitor probe to the ball of a neonatal foot. Oxygen saturation is expressed as a percentage of PO2. Measurements readings of 95 percent to 100 percent are considered normal values for a neonate transitioning to extrauterine life.

Every data collector in the study will be tested for interrater reliability. During the training sessions, the data collectors will be independently observed by two raters with at least two subjects utilizing the instruments developed for this study. This will ensure proper collection and recording of data.

Data analysis plan

The data collection for this study will be obtained by this researcher and two trained assistants. All three data collectors are Registered Nurses with backgrounds in Maternal Infant nursing. The procedures for collecting and recording data will be standardized. Collected data will then be organized and expressed as statistic which will support the test hypothesis that traditional nursing care at delivery for the healthy, term neonate is in fact an inferior care model for promoting extrauterine neonatal adaptation when compared with kangaroo care. A null hypothesis would be the no difference hypothesis, that is to say a finding of no difference between the temperatures and oxygen saturations of kangaroo care babies versus the infants receiving traditional nursery care. However, the possibility exists that traditional nursery care will be discovered to be a superior method of stabilization for healthy, term neonates.

The data obtained in this study will be analyzed using a multivariate analysis of variances or MANOVA. This method of analysis is useful for testing the difference between the means of two or more groups for two or more dependent variables simultaneously. Descriptive statistics will be utilized to provide an overview of the study participants and the results of application of the independent variable. Inferential statistics relating to the hypothesis of kangaroo care as a superior form of delivery room stabilization for term neonates will be presented.

The soft ware used to analyze the data will be the Epi Info. According to its web site, Epi Info is
      a set of programs for word processing, data management and epidemiologic analysis, designed for public health professionals. It consists of Epi Info (forms design, data entry, data management), Epi Map (generated geographical, map-based output), and SSS1 (Box-Jenkins time series analysis, MMWR graphs, trend analysis, and 2-source comparisons).
      URL:
      http://www.cdc.gov/epo/epi/epiinfo.htm

Plan for disseminating findings

The data obtained in this study will be relevant to all providers of delivery room care for mothers and neonates. It is anticipated that midwives and nurses will be most interested in the results of this study. Therefore, the final paper resulting from this study will be presented to nursery and labor and delivery staffs at Memorial Health University Medical Center, and also the other local hospitals and delivery sites. Plans for disseminating findings will include submission of a prepared manuscript for publication in JOGNN. The researcher also plans to present the results of this study to the local chapter of CNMs at one of their regular meetings.

References

Bauer, J., Sontheimer, D., Fischer, C., Linderkamp, O. (1996). Metabolic rate and energy balance in very low birth weight infants during kangaroo holding by their mothers and fathers. The Journal of Pediatrics, 129(4): 608-611.

Engler, A.J., Ludington-Hoe, S.M., Cusson, R.M., Adams, R., Bahnsen, M., Brumbaugh, E., Coates, P., Grieb, J., McHargue, L., Ryan, D.L., Settle, S., Williams, D. (2002). Kangaroo care: National survey of practice, knowledge, barriers, and perceptions. MCN, The American Journal of Maternal/Child Nursing, 27(3) 146-53.

Feldman, R., Eidelman, A.I. (2003). Skin-to-skin contact (kangaroo care) accelerates autonomic and neurobehavioural maturation in preterm infants. Developmental Medicine and Child Neurology, 45(4) 274-81.

Feldman, R., Eidelman, A.I., Sirota, L., Weller, A.(2002). Comparison of skin-to-skin (kangaroo) and traditional care: Parenting outcomes and preterm development. Pediatrics, 110(1) 16-26.

Feldman, R., Weller, A., Sirota, L., Eidelman, A. I. (2003). Testing a family intervention hypothesis: The contribution of mother infant skin-to-skin contact (kangaroo care) to family interaction, proximity, and touch. Journal of Family Psychology, 17(1): 94-107.

Franck, S., Bernal, H., Gale, G. (2001). Infant holding policies and practices in neonatal units. Neonatal Network, 21(2) 13-20.

Ludington-Hoe, S., Anderson, G.C., Simpson, S., Hollingsead, A., Argote, L.A., Rey, H. (1999). Birth-related fatigue in 34-36-week preterm neonates: Rapid recovery with very early kangaroo (skin-to-skin) care. JOGNN, 28(1) 94-103.

Ludington-Hoe, S.M., Nguyen, N., Swinth, J.Y., Satyshur, R.D.(2000). Kangaroo care compared to incubators in maintaining body warmth in preterm infants. Biological Research For Nursing, 2(1) 60-73

Morse, J.M., Field, P.A.(1995). Qualitative Research Methods for Health Professions. Thousand Oaks: Sage Publications.

Ohagi, S., Fukada, M., Moriuchi, H., Kusumoto, T., Akiyama, T., Nugent, J.K., Brazelton, T.B., Arisawa, K., Takahashi, T., Saitoh, H. (2002). Comparison of kangaroo care and standard care: Behavioral organization, development, and temperament in healthy, low-birth-weight infants through 1 year. Journal of Perinatology, 22(5) 374-9.

Polit, D., Beck, C., Hungler, B. (2001) Analyzing Quantitative Data, Essentials of nursing research: Methods, appraisal, and utilization. 5th ed. (pp. 327- 378). Philadelphia: Lippincott.

Roberts, K.L., Paynter, C., McEwan, B. (2000). A comparison of kangaroo mother care and conventional cuddling care. Neonatal Network, 19(4) 31-5.

Rosenberg, A.A. (2002). "The Neonate." In Obstetrics: Normal and Problem Pregnancies, edited by Gabbe, S.G., Niebyl, J.R., Simpson, J.L., 653-99. New York: Churchill Livingstone.

Seidel, H.M., Rosenstein, B.J., Pathak, A. (2001). Primary Care of the Newborn. St. Louis: Mosby, Inc:

Tortora, G.J., Grabowski, S.R. (2003). Principals of Anatomy and Physiology. New York: John Wiley and Sons, Inc. pp. 828.

Webster, (1996). Merriam Webster's collegiate Dictionary.(10th ed). Philippines: Merriam-Webster, Inc.

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Appendix A

Informed Consent


PHILADELPHIA UNIVERSITY IRB No. 123
CONSENT FOR PARTICIPATION IN
KANGAROO CARE RESEARCH


I, ___________________________________, consent to participate in research entitled
A Comparison of Kangaroo Care Versus Traditional Nursery Care
in Healthy, Term Neonates.

I understand that the purpose of this study is to examine Kangaroo care as a stabilization method for healthy, term newborns. Kangaroo care and traditional nursery care at delivery and for the first hour of life will be used. This study will provide information that will enable health care providers to give newborns optimal care at delivery to assist them in their transition from intra- to extra-uterine life.

I acknowledge that I have had the opportunity to obtain additional information regarding this study and that all questions I have raised have been answered to my full satisfaction.

Finally, I acknowledge that I fully understand the consent form. Participation in this study is strictly voluntary and I may withdraw my participation at any time. If I am selected for participation in the kangaroo care study, then I will agree to provide basic demographic data about myself which is relevant to the study. I understand that in order to collect the data being measured in this study that my infant will have a thermistor probe applied to his/her abdomen and one great toe. My infant will also have a pulse oximetry probe attached to the ball of one foot. Monitoring will occur for one hour. During the study period I will remain in my bed, in constant skin-to-skin contact with my infant. Once settled against my bare skin, my infant will be covered in a single cotton blanket folded into fourths. My body, except for the infant will be covered by my gown and my bedclothes as I desire. I may initiate breast feeding as I or my infant desire.

I understand that I will be in a partial state of undress throughout the study period and that a researcher will be in the room with myself and my infant throughout the study period. I understand that all attempts will be made to preserve my modesty and that I will only be uncovered in such a way as to allow medical personnel and the researcher visual access to my infant. No other restrictions upon my activity of state of dress will be made besides the ones previously described.

Participation in this study poses no known threat to the safety of my personal self or that of my newborn. The medical needs of myself and my infant take precedence over this study and will be promptly addressed by the appropriate medical personnel should such needs arise. There exists the possibility of skin abrasion or break down in the areas where the adhesive probes are applied to my infant. Care will be taken in the placement and removal of such probes so as to minimize the potential for injury.

Current research suggests that maternal infant bonding, breast feeding, neonatal stabilization and long term neonatal neurological development are all enhanced by early kangaroo care. Furthermore, research shows that maternal depression is reduced and family dynamics are improved by kangaroo care. The goal of this study is to collect data which supports kangaroo care as a method of delivery room stabilization for all healthy, term neonates.

Refusal to participate will not have a detrimental effect on the care given to myself or my newborn. A copy of this consent has been given to me. To protect human rights, I understand that this research proposal was reviewed and approved by the Institutional Review Board at Philadelphia University, as well as the Memorial Health University Medical Center practices and all its affiliated units.

The data obtained from this study will be coded and neither your nor your infant's identity will be revealed while the study is being conducted, reported or published. After this study is completed, all identifying data will be destroyed. For further information or concerns, call 1-912-355-9406 or e-mail janicecollinsioh@comcast.net.


Date:__________________________Signed:________________________________________
(Subject)


Signed:________________________Signed:________________________________________
(Principal Investigator) (Witness)



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Appendix B

Budget

Secretarial time to prepare consents, and data collection forms_________$600.00

Printing of consents, and data collection forms_____________________ $700.00

Assistance with statistical analysis of study data_________________________________$600.00

Statistical software SPSS___________________________________________________$300.00

Training cost for research assistants___________________________________________$300.00

Data collectors/ observers time (based on 3 RNs salary, 1.0 FTE each , approx. 1month)__________________$ 12,000.00

Data entry assistance (based on data clerk salary, for approx. two weeks) _________________$800.00

Lead researcher salary (based upon 0.2 FTE for approximately 2 months) __________$10,000.00

Thermistor probes (100) and Pulse Oximeter probes (50) ____________________$ 600.00



Total = $ 25,900.00



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Appendix C


Timetable

Proposal for IRB approval / approval from Memorial Health University Medical Center, and preparation of forms etc, for the study------------------------------------------------------------------------------------------------------------------ 3 months

Proposed time to complete data collection------------------------------------------------------1 month

Data entered and cleaned---------------------------------------------------------------- 3 months

Statistical Analysis of Data Entry and Interpretation of Data ----------------------------------------------------------------- 3 months

Writing up formal report -------------------------------------------------------------- 3 months

Total time for completion---------------------------- 1 year, 1 month


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Appendix D

Demographic Data Form

Please circle appropriate information

AGE IN YEARS:

ETHNICITY
Black
White
Hispanic
Native American Indian
Asian / Pacific Islander
Other

MARITAL STATUS
Married
Never married
Not married, significant other supportive of pregnancy
Divorced
Widowed

EDUCATIONAL LEVEL
Less than high school
High School graduate or GED
Technical or vocational training
Associate degree
Bachelor degree
Masters degree

OBSTETRICAL DATA
Gravida ______________
Parity _______________
Full term _____________
Preterm _____________
Abortion _____________

LMP ________________
EDD ________________
Weeks gestation at initiation of prenatal care __________
Pregnancy planned
Pregnancy unplanned
Planned feeding method: Breast or Bottle

Infant Data
Sex _________
1 minute Apgar score ________
5 minute Apgar score ________

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Appendix E

Data Collection Form


Subject ID #Abdominal TemperatureToe TemperatureOxygen Saturation (%)
5 minutes of age
10 minutes of age
15 minutes of age
20 minutes of age
25 minutes of age
30 minutes of age
35 minutes of age
40 minutes of age
45 minutes of age
50 minutes of age
55 minutes of age
60 minutes of age (1 hour)

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Appendix F

Observational Data Form


Subject ID #Maternal ActivityNewborn ActivityIs Kangaroo Care Being Maintained?
5 minutes of age
10 minutes of age
15 minutes of age
20 minutes of age
25 minutes of age
30 minutes of age
35 minutes of age
40 minutes of age
45 minutes of age
50 minutes of age
55 minutes of age
60 minutes of age (1 hour)
. . . . . . .