Evaluating the Effects of Kangaroo Care in the NICU
Conditions: Kangaroo Care, Premature Birth, Fathers
Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

v.11.24.2020 
Evaluating the Effects of Kangaroo Care 
in the NICU 
Principal Investigator: Craig Garfield, MD 
 
Protocol Date: 11/24/2020 
 
Funded by the Stanley Manne Children’s Research Institute 
 
 
 
 
 
 
 
 
 
 
 

v.11.24.2020 
Contents 
1. 
Background and Significance ............................................................................................................... 3 
2. 
Study Hypothesis and Outcomes ......................................................................................................... 4 
3. 
Study Design ......................................................................................................................................... 4 
4. 
Study Safety .......................................................................................................................................... 9 
5. 
Statistical Analysis .............................................................................................................................. 10 
6.     References .......................................................................................................................................... 11 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

v.11.24.2020 
1. Background and Significance 
Among 4 million infants born annually in the US, nearly 0.5 million are born prematurely 
(<37 weeks gestation) and cared for in Neonatal Intensive Care Units (NICUs). These preterm infants are 
extremely vulnerable in the perinatal period, with increased risks of physiologic instability, apnea, 
chronic intermittent hypoxemia, impaired temperature and metabolic regulation, and infection (1-7). 
Such prematurity-related complications are the leading cause of neonatal mortality and morbidity and 
result in longer average lengths of hospital stay and higher rates of re-hospitalization in preterm infants 
than in full term infants. Strategies to improve the physiologic stability and maturation of preterm 
infants during the critical perinatal period are vital to improve preterm infant outcomes, reduce life-long 
morbidity, and mitigate associated healthcare costs. 
 
Skin-to-skin contact between a preterm infant and a parent, also known as kangaroo care (KC), is an 
important, inexpensive modality deployed in the NICU to support the infant’s development and the 
formation of the parent-infant bond. During KC, a parent holds an infant against their bare chest, skin-
to-skin. NICU implementation of KC typically involves the mother (8), in a practice familiarly termed 
Kangaroo Mother Care (KMC). Over 1,000 articles supporting the implementation and positive effects of 
KMC have been published, outlining the positive effects of KMC intervention on physiologic and 
psychosocial outcomes.  KMC is invaluable in promoting strong mother-infant bonds, reducing morbidity 
and mortality, improving infant physiologic stability, and benefiting overall development trajectories. 
Additionally, KMC has also been shown to greatly benefit mothers, with improved initiation and 
duration of breastfeeding, reduced anxiety, and improved sense of confidence in parenting (10).  
 
In contrast to KMC, conspicuously little research has been published about the implementation and 
benefits of Kangaroo Father Care (KFC).  The limited preliminary data that are available support an 
association between KFC and improved preterm infant physiologic stability (e.g. heart rate variability, 
respiratory status, blood glucose, oxygen saturation (13)), infant contentment (e.g. crying episodes (12), 
time to relaxed state (13) and father-infant bonding (12). While both mothers and fathers have been 
noted to experience doubt, stress, anxiety, depression and loss of control (16) in the NICU, fathers are 
faced with different challenges than mothers (17,18). Specifically, fathers have been shown to feel less 
important and less needed than mothers (19), un-empowered in terms of active participation at the 
bedside, and relegated to return to work and handle external affairs (20). Fathers also report a lack of 
confidence in how to interact with and care for their premature infant, including a fear of caring for the 
infant based on the infant’s size and perceived fragility (17). Research suggests that these feelings can 
interrupt the father-infant bond (21). Additionally, fathers have been shown to hide their feelings and 
return to work while their infant is still in the NICU (19, 22-24) and to experience “pervasive uncertainty” 
when transitioning home (18). These feelings and experiences may further translate into individual and 
interpersonal stress, anxiety, and diminished parenting confidence.  KFC may be an effective mechanism 
to support fathers through these experiences, so they can, in turn, better support infants and mothers.  
 
Even though the short and long-term benefits, including cost-effectiveness, of KMC are clear and the 
World Health Organization recommends that KC be utilized as continuously as possible during the 
neonatal period (9), the benefits of KFC are only emerging and KC remains thoroughly under-utilized 
(14) in the NICU (15). We propose to revolutionize KC in the NICU by objectively measuring the effects of 
the KFC intervention on infants, fathers, and families. Utilizing wireless biosensor technology designed 

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by members of this team, our study will be the first of its kind to objectively evaluate KFC as an 
intervention for improving both acute and long-term outcomes of infants, mothers, and fathers in the 
NICU. 
2. Study Hypothesis and Outcomes  
2.1. Study Hypothesis 
The main hypothesis of this study is that Kangaroo Father Care (KFC) will positively impact acute 
physiologic and long-term behavioral outcomes in infants, fathers, and families. 
2.2. Outcome Measures 
2.2.1. Primary Outcome 
Primary outcome measures include heart rate (HR) and oxygen saturation (SpO2) as indicators of 
cardiorespiratory stability in infants before, during, and after KC and HR and HR variability (HRV) as 
indicators of physiologic stress in NICU parents during and after periods of KC. All of these outcomes will 
be measured using wearable, wireless biosensors. 
2.2.2. Secondary Outcomes 
Secondary outcome measures include 1) Accelerometry data captured using the wearable biosensors 
and compared to observations of infant position made by a study team member during  KC sessions to 
validate the accuracy of these biosensors in detecting body position and movement during KC; 2) Infant 
salivary cortisol reactivity, maternal salivary cortisol reactivity, and paternal salivary cortisol, 
testosterone, and oxytocin reactivity, compared before, during, and after KC; 3) Parenting confidence, 
relationship quality, and involvement scores as quantitated by the Parenting Sense of Competence Scale 
(PSOC), the Revised Dyadic Adjustment Scale (RDAS), the Postpartum Bonding Questionnaire, and a 
Father Involvement Scale at baseline, before discharge, two weeks after discharge, and four weeks after 
discharge. Two-sample t tests and mixed-effect linear regression models will be used to assess the mean 
between-group differences. Covariates such as age, education, socio-economic status (SES), stress and 
depression will be adjusted in the multivariable regression model.   
3. Study Design 
3.1. Eligibility Criteria 
3.1.1. Inclusion Criteria 
Infants: Infants who are born at Prentice Women’s Hospital between 30 0/7 and 36 6/7 weeks gestation, 
are ≤20 days old at the time of enrollment, and do not meet any of the study’s exclusion criteria will be 
eligible for participation in this study. Additionally, infants will only be included in this study if both of 
their biological parents are eligible and agree to participate.  
 
Parents: Parents who are ≥18 years of age, English speaking, expect mother and father to raise the 
infant together in the same household regardless of their marital status, and do not meet any of the 
study’s exclusion criteria will be eligible for participation in this study. Additionally, family units will only 
be included in this study if both biological parents of the infant are eligible and agree to participate.  

v.11.24.2020 
Only English speaking parents will be included in this trial because the study questionnaires are only 
available in English. 
3.1.2. Exclusion Criteria 
Infants: Infants who are intubated or sedated, are receiving vasopressors or analgesics, have any 
congenital anomalies or skin abnormalities deemed likely to impact KC by clinical team, have received or 
are planned to receive surgical intervention that will impact the utilization of KC, wearable sensors, 
and/or oral swabs, or are experiencing other symptoms or receiving other intervention that will impact 
the utilization of KC, wearable sensors, and/or oral swabs will be excluded from this study. 
 
Parents: Parents who are showing any signs of illness or taking corticosteroids or testosterone 
supplementation will be excluded from this study. Non-English speaking parents will also be excluded 
from this study because the questionnaires associated with this study are only available in English. 
3.2. Screening and Consent 
Families who qualify for participation in this study will be identified through review of electronic medical 
records. Once a potential subject is identified, a study team member will consult the NICU care team in 
order to assess the condition of the infant and determine the family’s approachability for discussion of 
the study. If the clinical care team feels a family is approachable, a member of the study team will 
identify the best time to meet with the family. All participation will be discussed at the infant’s bedside 
in a private room. 
 
During this discussion, the study team member will outline the following study details for the family: the 
rationale of the study, the specifics of data and specimen collection, the study team’s legal and ethical 
obligations and practices to ensure confidentiality, the physiologic monitoring by wearable, wireless 
biosensor, the KC interventions, the salivary sample collection, the saliva questionnaires and the 
psychosocial questionnaires and follow-up. The study team member will also discuss the risks of 
participation, which include the risks of adverse reaction to the adhesive used on the wearable, wireless 
biosensors. The family will be informed that their commitment or refusal to participate will not affect 
the care their child receives in the NICU and will be completely optional and anonymous. A copy of the 
Informed Consent document will be provided to each family. The family will then be left with the 
consent form to review discuss privately. After this period of private review, the study team member 
will return and give parents the opportunity to ask questions. Once all questions are answered, the 
parents will be asked to describe the study process as they understand it in their own words. To 
minimize the amount of time the study team spends in the infant's bed space an infant's parent(s) may 
provide consent over the phone or a secure telecommunication platform such as Skype for Business. 
The consent process as described above will not change. The family will be provided written materials 
describing the nature of the optional elements and given an opportunity for questions and private 
discussion. 
 
Consent obtained over the phone or secure telecommunication platform will be obtained according to 
institutional policy. A member of the study team will explain in detail and review the informed consent 
document(s) with the parent(s). If the parent(s) agree to participation, they will sign a copy of the 
informed consent document(s) and the study team member obtaining consent will sign a copy at the 

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same time. The parent(s) will be required to send their signed document(s) to the study team by mail, 
fax, or email, and the two signature pages will be combined. The parent(s) will be provided a copy of the 
fully executed, signed informed consent document(s) by mail, fax, or email prior to any study 
procedures. 
3.3. Study Procedures 
Screening: 
Participants will be recruited from the NICU at Prentice Women’s Hospital. A member of the study team 
will screen all NICU patients for inclusion and exclusion criteria by reviewing electronic medical records. 
A screening and enrollment log will be kept to track families who have been approached and agreed or 
declined to participate in the study. The screening and enrollment log will be kept on a secure REDCap 
server housed by Northwestern University. Only the study team will have access to this log. 
 
Kangaroo Care (KC) Intervention: 
After enrollment, families will be scheduled to participate in two sessions of KC. The goal will be to 
schedule the KC sessions over two sequential days and at approximately the same time of day (i.e. 
morning, afternoon, or evening). However, if this is not possible given the parents' schedules, the 
sessions will be scheduled for the days and time of day that participating parents are able to visit their 
infant in the NICU. Each session will include two hours of continuous KC, with one day focused on 
Kangaroo Mother Care (KMC) and the other on Kangaroo Father Care (KFC), in a randomized order. 
These sessions will include continuous skin-to-skin holding of the infant by the parent, per standard of 
care protocol. 
 
Physiologic Recording: 
Infant: Prior to the first scheduled KC session, two wearable, wireless biosensors will be placed on the 
infant to continuously capture physiology measures including electrocardiogram (ECG), heart rate (HR), 
oxygen saturation (SpO2), body temperature, respiratory rate, movement, systolic blood pressure (BP-
S), and others for the duration of the study. One device will be placed on the infant’s chest or back. A 
second device will be placed peripherally, on the infant’s leg, foot, arm, or hand. The devices are 
encapsulated in a medical-grade silicone and will be adhered to the infant’s skin using a medical-grade 
adhesive, similar to the adhesives standardly used in the NICU. The biosensors will be left in place for up 
to 48 hours, but will be checked by study staff at least once every 24 hours to ensure skin integrity and 
signal quality. The adhesives will be changed between uses.   
 
Parent: The same type of wearable, wireless biosensor will also be used to record 4 hours of continuous 
physiology including ECG, HR, temperature, movement, SpO2, and others in the infant’s parents. The 
biosensor will be placed on the parent’s chest 1 hour before the start of a scheduled KC session and 
worn for 1 hour preceding the scheduled KC session, during the 2-hour KC session, and for 1 hour after 
the completion of the KC session. The biosensor will be worn by the parents for approximately 4 hours 
in total. 
 
Skin Monitoring: 
Before and after the wearable biosensors are placed on the infant, the infant’s skin integrity will be 
evaluated using a neonatal skin scoring measure for monitoring skin integrity. Study staff will take 

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photographs of the skin at the site of biosensor placement before the biosensors are placed and after 
the biosensors are removed. Skin changes occurring while the biosensor is adhered to the infant’s skin 
will be documented photographically. No faces will be photographed. The study team will consult the 
bedside care team within 1 hour for any changes in skin integrity (based on the neonatal skin integrity 
score). 
 
Saliva Sample Collection: 
Saliva will be collected from enrolled infants and parents non-invasively to evaluate the effects of KFC on 
established biomarkers of stress (cortisol and testosterone) and father-infant bonding (oxytocin).  
Before, during, and after each KC session, saliva will be collected from the participating parent, and their 
infant.  A trained member of the study team will collect saliva from the infant using suction, a method 
that follows the standard of care for the infant, or oral swabs (27) made from an inert polymer and 
appropriately sized for an infant mouth (approximately 5 mm). Saliva samples will be taken from the 
infant immediately prior to beginning a KC session (T1), 30 minutes into the KC session (T2), and 
30 minutes post-session (T3). Parents will self-collect saliva samples at the time points outlined above, 
using an adult-sized oral swab. At T2, the trained study team member will be able to help the parent 
collect the saliva sample, if necessary, while the parent continues to hold their infant. This approach to 
salivary sample collection and biomarker analysis is similar to that established by previous studies of 
kangaroo care (26,27) and takes into consideration the 30-minute delay before cortisol reactivity in 
saliva. 
 
Saliva Questionnaires: 
When saliva is collected from parents at time points T1, T2, and T3, parents will also be asked to 
complete a brief saliva questionnaire. These questionnaires will take approximately five minutes each to 
complete and will be completed on paper or directly in REDCap, depending upon the participant’s 
preferences. At T2, a study team member will be able to help the parent complete the survey, if 
necessary, while the parent continues to hold their infant.  Data provided on surveys completed on 
paper will be transferred to secure REDCap forms by study staff and destroyed within 24 hours. All 
questionnaire data will be stored long term on the secure REDCap server housed by Northwestern 
University. 
 
Psychosocial Questionnaires: 
This study will employ psychosocial measures to capture the short- and long-term impacts of 
KFC. Specifically, validated measures of parenting confidence, relationship quality, infant bonding, and 
father involvement will be assessed via a set of  paper or REDCap surveys administered in the NICU 
(short term) at baseline and the day before discharge (T-1) , and at home (long term) at 2 weeks (T+14) 
and 4 weeks (T+30) after discharge. Each of these sets of surveys will take approximately 30 minutes to 
complete. At baseline, each parent will complete the Revised Dyadic Adjustment Scale (RDAS) and the 
Postpartum Bonding Questionnaire (PBQ). At T-1, each parent will complete the RDAS , the PBQ, and the 
Parenting Sense of Competence Scale (PSOC). These questionnaires will be completed on paper or 
directly in REDCap, depending upon the participant’s preferences. Data provided on surveys completed 
on paper will be transferred to secure REDCap forms by study staff and destroyed within 24 hours. At 
T+14 and T+30, each parent will complete the RDAS, the PBQ, the PSOC, and a Father Involvement 
Questionnaire. These questionnaires will be completed directly in REDCap only. Each parent will 

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receive an email containing a link to their set of questionnaires at both post-discharge time points. All 
questionnaire data will be stored long term on the secure REDCap server housed by Northwestern 
University. 
 
Wearable Sensor Data Collection: 
The wearable sensor that will be used in this study can stream data continuously using near field 
communication (NFC) or Bluetooth technology. An encrypted laptop, iPad, or similar device will be left in 
the patient room and used to capture the continuous data stream from the wearable sensor. 
Additionally, wearable biosensors can include onboard memory, and physiologic streams may be 
recorded to this onboard memory until transfer to an encrypted laptop for analysis. 
 
We have recently upgraded a new firmware version activating the ability for the sensor to continuously 
measure bioimpedance for respiratory rate. This function does not require any modification to the 
physical device itself or the adhesive. However, the bioimpedance functionality does require delivery of 
low amplitude sinusoidal current through the electrodes of the chest unit. The frequency of the current 
is 4 kHz – a frequency range used typically for human bioimpedance measurements by FDA cleared 
systems. The maximum current delivered is 8 μA. The sensors with these parameters are safe to be 
worn by the infants for the duration of the study, which is up to 48 hours. These parameters are below 
commonly used body fat percentage impedance analyzers that are widely commercially available. 
Furthermore, bioimpedance is standard measurements in existing NICUs / PICUs leveraging the ECG 
electrodes that are then displayed on standard of care monitors. Commercially bioimpedance devices 
that are FDA approved inject currents that are 10x greater than our system (e.g. the CoVa Monitoring 
System 2 for continuous wearable sensing of thoracic impedance). Finally, the parameters in our sensor 
follow IEC 60601-1-2 guidelines for electromagnetic safety. 
 
Standard of Care Data Collection: 
In all patients in rooms where data from standard of care monitoring is recorded on the BedMaster 
system, this data will be used for comparison to data captured using the wearable sensors. In 
participants in rooms where this system is not available, the MediCollector system will be used to 
capture background data during the approximately 48-hour study. 
3.4. Study Timeline 
Activity
Duration
Study Set-up
12/2018-3/2019
Recruitment
2/2019-5/2021
Data Collection
2/2019-5/2021
Final Data Analyses + Report
12/2019-12/2021
 
 
 
 

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4. Study Safety 
4.1. Privacy Protections 
The study team will take measures to protect the privacy and confidentiality of participants. The plan to 
protect patient privacy includes approaching and consenting participants in a private room. Study 
procedures will be done in the privacy of the patient rooms in the ICU. Study participation discussions 
will be limited to members of the study staff and the involved participants. 
Participant data will be coded with study identifier only. All data obtained from the bedside monitors 
will be stored on the Azure Cloud (maintained by Data Analytics Reporting (DAR) at Lurie Children’s). All 
data obtained using wearable sensors will be stored on an encrypted laptop and secure network for 
later analysis. All questionnaire responses will be collected via Research Electronic Data Capture 
(REDCap) hosted by Northwestern University. When preferred, parents can fill in questionnaires on 
paper, and these will be transferred to REDCap by study staff after collection.  
To minimize the risks, only the minimum data necessary to complete the study will be collected on each 
study participant. 
Photographs will be labeled only by study code, and will not include subject’s face. Video may include 
the subject’s face, but all videos will be scored for position and movement within 1 month of recording, 
and will be deleted after scoring.  All photos and videos will be stored on a password protected server 
accessed by a password protected computer. 
Only authorized personnel listed in the IRB application will have access to study data. The screening and 
enrollment log used contain the code link, and this file will be stored on the REDCap server and will have 
access limited to the study team. The link between the participants and their study identifier will be 
destroyed at the conclusion of this study, so all remaining data will be fully de-identified.  
Data transferred to the study team by the NU electronic data warehouse for patients meeting screening 
criteria in the Prentice NICU will be downloaded onto the Lurie Children's Hospital server. This data file 
will be used for up to one week to allow the screening process to take place, then will be deleted.  
Confidentiality will be maintained with all of the medical records of this study. Subject records will be 
kept in a locked cabinet, under the control of the Principal Investigator. The subject will also be assigned 
a code in the data sheets so that the records on the computer will be kept confidential.  
Potential Risks 
Sensor Risks: There is a risk of discomfort or irritation from the adhesives used with wearable, wireless 
biosensors. It is possible that the additional handling required to place the biosensors may be 
temporarily disruptive for the participants. Study staff will check on the participant at least once every 
24 hours to monitor for signs of discomfort, irritation, or allergic reaction. Skin integrity will be scored 
according to the protocol, and the bedside team will be consulted within 1 hour for any concerns. Any 
adverse events or evidence of discomfort during monitoring will be recorded and the bedside team will 
be immediately consulted. Photographs will be taken at baseline and after study; skin changes during 
the period of wearable biosensor use or at subsequent time points will be documented 
photographically. 
 

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Parent Questionnaire Risks: Some questions may make parents uncomfortable or upset. It will be made 
clear to the parents that they do not have to answer any questions that make them feel uncomfortable 
or upset. The parents will be informed that they can end their participation in the study at any time 
4.2. Discontinuation Criteria 
A participant may be discontinued if the participant is unwilling or unable to tolerate the wearable 
sensors, saliva collection, or skin-to-skin session. Examples may include adverse reactions to the 
adhesive on the wearable sensors or a patient removing the wearable sensors. The bedside clinical team 
or family can also request discontinuation at any time.  Families participating in the video monitoring 
can request discontinuation of the video monitoring aspect of this study at any time during the study.  
4.3. Patient Withdrawal 
Any participants withdrawn from the study will have the wearable sensors removed immediately. Any 
data collected prior to the withdrawal will remain a part of the study, and this data will be coded. 
5. Statistical Analysis 
5.1. Statistical Plan 
Measurements made through clinical standard of care will be compared to the measurements recorded 
by the wearable sensors. Distribution checks for normality and data accuracy will be completed for each 
individual and for the entire study prior to all analyses. For continuous measures of physiology, 30 
second epochs will be defined for each method for comparison. 
 
Agreement and correlation of wearable biosensor measures to standard of care measures will be 
assessed in two ways. First, Bland–Altman plots will be created to assess agreement between each 
measurement system via bias and precision, which reflect the mean or average difference between two 
methods and the variation in these differences, respectively. Our second method consists of individual 
correlations between methods assessed for each person. This correlational method will supplement 
additional methods, and can be directly transformed to variance shared between wearable biosensor 
and standard of care measures, a common metric of reliability of any measure. 
 
Formal tests of bias, precision, and correlations: While the above methods will yield useful statistics, 
they need to be extended to deal with the structured nature of our data. Specifically, our data are 
clustered, meaning that we have multiple observations within each person and multiple people in our 
sample, which violates standard independence assumptions inherent to many models. We propose to 
estimate bias and correlation/reliability using multi-level models, which yield the same statistics 
discussed above but account for the fact that observations taken from the same patient are more 
related than comparisons involving different patients. 
 
Data will be cleaned and analyzed using IBM SPSS Statistics 20.0, unless a newer version of SPSS is 
available. Using repeated-measures analysis of variance (RM-ANOVA), with the study phase (pre-, 
during-, and post-kangaroo care) as the repeated factor, we will test differences across study phase for 
maternal cortisol, paternal cortisol, infant cortisol, paternal oxytocin, and paternal testosterone. We will 
use a two-tailed test with a 5% level of significance analysis. In addition to tracking changes over the 
period of kangaroo care, we will also examine within-triad correlations in cortisol for mother-father-

v.11.24.2020 
infants in the same family, as well as correlations between infant cortisol and father 
testosterone/oxytocin, and maternal cortisol and father testosterone-oxytocin. 
 
Statistical Power: The large amount of within-person data provides incredibly high statistical power for 
all planned and many secondary data analyses, allowing this data set to answer all proposed questions. 
Previous work on power in multilevel models found greater than 99% power to detect associations with 
the planned observations suggested here within comparable nested designs. 
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