Investigating the Impact of Skin to Skin on Preterm Infant Heart Rate Variability
Phase: NA
Conditions: Heart Rate Variability, Preterm Infant
Sponsor: University of New Mexico

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PROTOCOL TITLE: 
Investigating the Impact of Skin to Skin on Preterm Infant Heart Rate Variability 
PRINCIPAL INVESTIGATOR: 
Jessie Maxwell, MD 
Department of Pediatrics 
Division of Neonatology 
 
ADMINISTRATIVE CONTACT: 
 
Name Sandra Beauman 
 
Department Pediatrics 
VERSION NUMBER: 
Version 3 
DATE: 
June 21, 2021 
REGULATORY FRAMEWORK: 
Please indicate all that apply (please note that the regulatory framework does not 
mean the funding source): 
☐ 
DOD (Department of Defense) 
☐ 
DOE (Department of Energy) 
☐ 
DOJ (Department of Justice) 
☐ 
ED (Department of Education) 
☐ 
EPA (Environmental Protection Agency) 
☐ 
FDA (Food and Drug Administration) 
☒ 
HHS (Department of Health and Human Services) 
☐ 
VA 
☐ 
Other:       
 
FUNDING: 
This project is not currently funded. The supplies required to complete this project, 
including the incentives for participants, will be funded from the fellow’s research funds. 
 
CLINICAL TRIALS 
Is this a clinical trial per the NIH definition of a Clinical Trial?   ☒ Yes   ☐ No 

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NIH Definition of a Clinical Trial:  
“A research study in which one or more human subjects are prospectively assigned to one 
or more interventions. An "intervention" is defined as a manipulation of the subject or 
subject’s environment for the purpose of modifying one or more health-related 
biomedical or behavioral processes and/or endpoints. Examples include: drugs/small 
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery 
systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related 
behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related biomedical 
or behavioral outcomes.”  
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:        
 
Does the study involve human participants? ☒ Yes   ☐ No 
 
Are the participants prospectively assigned to an intervention? ☒ Yes   ☐ No 
 
Is the study designed to evaluate the effect of the intervention on the participants? 
☒ Yes  ☐ No  
 
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
☒ Yes   ☐ No 
 
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of 
a clinical trial, even if…  
• You are studying healthy participants 
• Your study does not have a comparison group (e.g., placebo or control) 
• Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug 
• Your study is utilizing a behavioral intervention 
 
If yes to all 4 questions, please confirm that the research team is familiar with and agrees 
to comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database   ☒ Yes   ☐ No  
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu  
 

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Table of Contents 
1. 
Objectives .................................................................................................................... 5 
2. 
Background .................................................................................................................. 5 
3. 
Study Design ............................................................................................................... 5 
4. 
Inclusion and Exclusion Criteria ................................................................................. 6 
5. 
Number of Subjects ..................................................................................................... 7 
6. 
Study Timelines ........................................................................................................... 7 
7. 
Study Endpoints ........................................................................................................... 7 
8. 
Research Setting .......................................................................................................... 7 
9. 
Resources Available .................................................................................................... 8 
10. 
Prior Approvals ........................................................................................................ 8 
11. 
Multi-Site Research ................................................................................................. 9 
12. 
Study Procedures ..................................................................................................... 8 
13. 
Data Analysis ........................................................................................................... 9 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects ............................ 9 
15. 
Withdrawal of Subjects .......................................................................................... 11 
16. 
Data Management/Confidentiality ......................................................................... 10 
17. 
Data and Specimen Banking .................................................................................. 13 
18. 
Risks to Subjects .................................................................................................... 10 
19. 
Potential Benefits to Subjects ................................................................................ 14 
20. 
Recruitment Methods ............................................................................................. 14 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 11 
22. 
Economic Burden to Subjects ................................................................................ 15 
23. 
Compensation ........................................................................................................ 12 
24. 
Compensation for Research-Related Injury ........................................................... 12 
25. 
Consent Process ..................................................................................................... 16 
26. 
Documentation of Consent .................................................................................... 12 
27. 
Study Test Results/Incidental Findings ................................................................. 20 
28. 
Sharing Study Progress or Results with Subjects .................................................. 20 
29. 
Inclusion of Vulnerable Populations ...................................................................... 13 
30. 
Community-Based Participatory Research ............................................................ 22 
31. 
Research Involving American Indian/Native Populations ..................................... 22 
32. 
Transnational Research .......................................................................................... 22 
33. 
Drugs or Devices .................................................................................................... 23 
34. 
Principal Investigator’s Assurance ........................................................................ 23 
35. 
CHECKLIST SECTION ........................................................................................ 25 
36. 
Partial Waiver of Consent for Screening/Recruitment .......................................... 25 
37. 
Partial Waiver of HIPAA Authorization for Screening/Recruitment .................... 26 
38. 
Waiver of Documentation of Consent ................................................................... 26 
39. 
Alteration of Consent ............................................................................................. 27 
40. 
Full Waiver of Consent/Parental Permission ......................................................... 28 
41. 
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
 
29 
42. 
Full Waiver of HIPAA Authorization (Checklist) ................................................. 29 
43. 
Other Waiver Types (Checklist) ............................................................................ 30 
44. 
Vulnerable Populations (Checklist) ....................................................................... 30 
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45. 
Medical Devices (Checklist) ................................................................................ 196 
46. 
Export Control (Checklist) ................................................................................... 207 
47. 
Data Transfer/Sharing (Checklist) ....................................................................... 207 
48. 
Specimen Transfer/Sharing (Checklist) ............................................................... 218 
 
 
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1. Objectives 
The objective of this study is to monitor heart rate variability in preterm infants 
receiving respiratory support, including conventional mechanical ventilation, 
during skin-to-skin care. We hypothesize that skin to skin care will be associated 
with a more mature pattern of parasympathetic activity as measured by various 
domains of heart rate variability. Specifically, the standard deviation of the 
normal-to-normal interval (SDNN), the root mean squared of successive 
differences of normal-to-normal intervals (RMSDD), and the standard deviation 
of deceleration (SDDec) will decrease in infants that are receiving skin-to-skin 
care across all types of respiratory support compared to infants who are lying in 
their isolette. 
2. Background 
Kangaroo Mother Care (KMC), caring for newborns on their mother’s chest 24 
hours/day, has shown to be effective for thermal control, breastfeeding and bonding in 
newborns and was initially used in resource limited countries to reduce mortality in low 
birthweight infants [1]. For infants with a birthweight <2000g born in low- or middle-
income countries, initiating KMC within the first week of postnatal life resulted in 51% 
reduction in mortality [1]. KMC has also been found to decrease health care related 
sepsis and improve infant growth [1]. Most neonatal intensive care units are familiar 
with skin-to-skin care, intermittent, usually short-term placement on mother’s (or 
father’s) chest, as a means to enhance breastfeeding, attachment and parental self-
esteem, and studies have shown that it is safe for both non-intubated and intubated 
preterm infants to complete skin to skin care [1,2,3].  
The autonomic nervous system, comprised of sympathetic and parasympathetic 
innervations, is incomplete at birth. In premature infants the sympathetic tone is 
dominant. Improved parasympathetic tone promotes growth and restoration in addition 
to energy conservation [4]. 
Heart rate variability (HRV) is the temporal variation between sequences of 
consecutive heart beats, measured by the normal to normal (NN interval) which is the 
period between adjacent QRS complexes [5]. HRV measures the balance between 
sympathetic and parasympathetic mediators of heart rate. HRV increases with 
gestational age, and lower heart rate variability reflects low parasympathetic activity in 
infants [7,8]. Studies have shown that reduced heart rate variability in a fetus, which is 
detectable prior to a change in normally measured heart rate, is a marker of fetal distress 
[6]. HRV measurements may be useful in capturing clinical dynamic changes in 
autonomic regulation in response to skin-to-skin care [8,9].  
 
3. Study Design 
This will be a prospective crossover study, with each infant serving as their own control. 
Any infant for whom the parent has consented to participate in the study will have heart 
rate variability leads applied and be monitored before, during and after a skin-to-skin 
session with the infant’s parent. Due to the nature of the study, blinding is not feasible. 
Infants will remain on the hospital cardiac monitor during the study to maintain standard 
of care, and data obtained in this study will not be used for clinical care. All sessions 
will occur during the infant’s NICU admission.   

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4. Inclusion and Exclusion Criteria 
Inclusion Criteria: 
• Infants must be £ 30 weeks gestational age at time of delivery. 
• Both inborn and outborn infants are eligible for this study. 
• Infants must be less than 6 weeks postnatal age. 
• Infants must have had a cranial ultrasound with results showing no 
intraventricular severe intraventricular hemorrhage (Grade III or IV) [10]. 
• Infants must require respiratory support at the time of the first session. This 
will include mechanical ventilation, noninvasive positive pressure 
ventilation (NIPPV), continuous positive airway pressure (CPAP), high 
flow nasal cannula (HFNC) or low flow nasal cannula (LFNC). 
• Consenting biological or legal adoptive mother of the infant must speak 
English. If the study is unable to enroll an appropriate number of patients, 
will consider including non-English speaking patients. However, due to 
limited resources for this study, we will start with only English-speaking 
patients. Biological or legal adoptive mother will provide consent for the 
infant to participate in this study.  
• Biological or legal adoptive fathers of the infant are eligible to complete 
skin to skin sessions with the infant. As we are not collecting any 
information from the father, and skin to skin is a part of accepted standard 
of care, consent will not be obtained from the father.  
• Infants of employees are eligible to participate. Undue influence or coercion 
will not be applied to infants of employees and participation or lack thereof 
will not affect employment status. 
 
Exclusion Criteria: 
• Infants who have not received a head ultrasound. 
• Infants with grade III or higher intraventricular hemorrhage identified on a 
head ultrasound. 
• Infants on high frequency ventilation, due to the artifact transmitted to ECG. 
• Infants with known genetic disorders or known prenatal chromosomal 
anomalies. 
• Infants with one or more major congenital anomaly. 
• Infants undergoing active sepsis evaluation or treatment for infection. 
• Infants on blood pressure or cardiac medications or infusions including 
inotropic mediations. 
• Mothers (biological or legal adoptive) that are <18 years of age will not be 
approached for consent. 
• Mothers (biological or legal adoptive) who are unable to provide consent 
due to having a legal representative will not be approached for consent in 
this study. 
• Mothers (biological or legal adoptive) who are prisoners will not be 
approached for this study as participation requires multiple skin to skin 
session with the infant.  

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Infants will be screened for eligibility by reviewing the Newborn Intensive Care Unit 
(NICU) census daily. Consent will be obtained after an infant has delivered. No pregnant 
women will be approached for consent.  
 
Any infant who has been consented for participation and completes at least 1 skin to skin 
session will be included in the final study sample. As skin to skin is part of standard of 
care, and information, aside from gender, will not be obtained from the parent, consent will 
be obtained for the infant to participate in the study. Consent for the parent to participate 
will not be necessary.  
 
5. Number of Subjects 
This is a single site crossover study design. The goal number of patients to be recruited 
is 10.  The number of extremely preterm infants £30 weeks gestation born at UNMH 
averages approximately 60-70 per year.  Anticipating that most of these infants will be 
eligible and the consent rate will be about 50%, as this is not a drug study, we expect to 
reach goal enrollment within 1 – 1 ½ years. 
Previous studies of HRV analysis in preterm infants have found significant differences 
(alpha of 0.05) when enrolling 10 or more infants in the study[11,12]. Therefore, utilizing 
this information, the sample size of 10 has been determined for this study.  
 
6. Study Timelines 
An infant will participate in the study if the mother consents for participation. 
Maximum duration of participation is limited to the first 6 weeks of life.  
The duration of time to enroll subjects is 18 months. If the goal enrollment is reached 
sooner, then the enrollment will be stopped. Data will be analyzed after 2 infants have 
completed the study to make sure data is being captured correctly and on completion of 
goal enrollment. Data analysis is expected to be completed within three months after 
enrollment is complete. Total study duration is expected to be 18-24 months.  
 
7. Study Endpoints 
The primary endpoint of the study will be obtaining the heart rate variability 
measurements at three time points. Specifically the standard deviation of the normal-to-
normal interval (SDNN), the root mean squared of successive differences of normal-to-
normal intervals (RMSDD) and the standard deviation of deceleration (SDDec) measured 
before, during, and after a skin to skin session.  
As this study is no more than minimal risk, a data safety monitoring board will not be 
required. However, during the enrollment period, a safety review will be completed by the 
study team after every patient to assess skin integrity and to provide any reports needed to 
the IRB in a timely manner.  
In addition to the aims presented, an exploratory aim will evaluate the differences in 
heart rate variability of preterm infants between mothers and fathers performing skin-to-
skin care. The study will collect the gender of the parent performing skin to skin with the 
infant for each session. 
 
8. Research Setting 

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The research will be conducted in the Newborn Intensive Care Unit (NICU) at the 
University of New Mexico Hospital (UNMH). Patients will be identified after admission 
to the NICU. The application of the Heart Rate Variability monitor will occur in the NICU 
as well.  
 
9. Resources Available 
Dr. Maxwell is a neonatologist who conducts basic, translational and clinical research 
when not on service in the NICU. She has dedicated research time, and thus has the 
availability to complete the proposed project. She is well experienced in caring for this 
patient population. Her involvement on an IRB committee has significantly increased her 
knowledge in regard to ensuring that all research is conducted in the highest quality 
possible. Dr. Maxwell also has experience in utilization of HRV in neonates and can 
provide expertise in this area.  
Dr. Watterberg has over 30 years of experience conducting studies in the newborn 
population. She is the New Mexico principal investigator for the NICHD Neonatal 
Research Network, which has multiple ongoing observational and interventional studies. 
She has mentored fellows, faculty and other learners in research and academic 
advancement. 
Dr. Swieter is a neonatology fellow at UNMH. She has dedicated research time, and 
thus has the availability to complete the proposed project. Additionally, Dr. Swieter has 
research funds available to provide monetary support for the project, including the gift 
cards as described. 
All research persons will remain up to date on CITI training and on the most recent 
version of the IRB-approved protocol for this study. Additionally, research persons have 
availability to all patients admitted to the NICU that meet inclusion criteria, making the 
goal recruitment of 10 infants over 1 year feasible.  
 
10. Prior Approvals 
The departmental approval has been obtained and is uploaded for review. 
 
11. Multi-Site Research – N/A 
 
12. Study Procedures  
Any infant that is born £ 30 weeks gestational age and does not meet exclusion criteria 
as described above will be considered for this study. If an infant is born at another hospital 
and transferred to UNMH, they will be considered for the study when the mother is 
physically present to consent if inclusion criteria are met.  
The study will be described following the consent script (attached). If consent is given, 
the infant will then be given a unique study identifier (HRV1, HRV2). 
The AcqKnowledge HRV device will be applied 30 minutes prior to a skin-to-skin 
session with the infant’s mother or father (only the gender of the individual will be 
collected from the caregiver at the time of the session) and remain in place until 30 minutes 
following the end of a skin-to-skin session. This will allow a minimum of 90 minutes of 
data collection (30 minutes pre skin-to-skin, 30 minutes during skin-to-skin, and 30 
minutes post skin-to-skin), depending on the duration of skin-to-skin time. If the infant is 
tolerating skin to skin, the session may last longer than 30 minutes. The data output will 

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not be visible to the clinical team, so there will not be any incidental clinical interpretation 
of the data.  
 
To apply the device, three leads with a drop of gel on each lead will be applied to 
the infant. Additionally, the pneumogram will be placed on the skin above the diaphragm. 
The leads and the pneumogram will be plugged into the HRV monitor, which is connected 
to a laptop computer and will remain at the bedside throughout the study session. Care will 
be taken to remove the sensors, using massage oil, following each skin-to-skin session. The 
sensors will then be discarded after use. The area of application of the sensors will be 
assessed upon completion to ensure skin integrity remains and there is no/minimal 
irritation. 
 
Infants will be transferred to their mother or father following the unit protocol for 
transfer of ventilated infants for skin to skin care. Data will be collected from the infant’s 
medical record. We will collect the gender of the individual completing the skin to skin 
session so that the exploratory aim can be completed.  
 
Information will be collected from the medical record at time of enrollment as well 
as at each skin-to-skin session. This information will include the infant’s gestational age at 
birth, postnatal age, birth weight, mode of delivery, infant’s sex, any resuscitation required 
at time of birth, the length and type of breathing support required, any surgeries during the 
hospitalization, the hospital length of stay, any common complications babies have from 
being born early including intraventricular hemorrhage (bleeding in the brain), necrotizing 
enterocolitis (complication in the bowel), current medications, infectious work ups and 
death during the study period if applicable.  
 
13. Data Analysis 
As this study is essentially a pilot study, with goal recruitment of 10 patients, the 
statistics will be exploratory, but modeled after a Cong et al pilot study that looked at 
kangaroo care in the preterm infant and heart rate variability in response to a heel stick 
[13]. We plan to calculate the geometric mean [GM = (a1 · … · an)1/N] instead of the 
arithmetic mean [M = (a1 + … + an)/N] for calculating HRV indices, because the GM 
results in an average rate of change. Repeated measures of analysis of variance (RM-
ANOVA) will be used to compare HR and HRV across the pre, during and post skin to 
skin sessions.  
The primary endpoint of the study will be to obtain heart rate variability measurements 
at three time points. Specifically the standard deviation of the normal-to-normal interval 
(SDNN), the root mean squared of successive differences of normal-to-normal intervals 
(RMSDD) and the standard deviation of deceleration (SDDec) measured before, during, 
and after a skin to skin session. 
 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects 
This study is seen as no more than minimal risk to the patient population because skin-
to-skin care currently occurs within this population. Scientific literature will also be 
reviewed throughout the study to ensure that the study protocol remains appropriate for the 
patient population. Any concerns or significant adverse events will be reported to the IRB 
immediately. As this study is no more than minimal risk, a DSMB is not required.  
 
15. Withdrawal of Subjects 

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If a parent decides to withdraw the infant from the study, any data that has already been 
collected will be kept for analysis, unless the PI has been contacted as described in the 
following sentence. If the mother wishes to remove collected data, then they can contact 
the PI, Dr. Maxwell, at 630-864-9422 to request all data to be removed; the data will then 
be removed. No additional data will be collected.  
 
The investigators conducting the study may need to remove the infant from the 
study if the mother or father completing skin to skin sessions is not able to follow directions 
or if participation of the infant is found to have more risk than benefit. 
 
16. Data Management/Confidentiality 
All data will be kept on a password protected computer or external hard drive in the 
neonatology fellow office, in a locked cabinet, which is behind a locked office door and a 
locked hallway. All paper records will be kept in a locked cabinet in the neonatology 
fellow’s office, which has a locked office door and a locked hallway. All electronic data 
will be de-identified as soon as possible with identifying information stored separately 
from study data. All de-identified information will be kept until the youngest subject 
reaches the age of 22, as required by UNM HSC Research Policy, and then destroyed. 
Upon graduation of the fellow, the study documents will be transferred to Dr. Maxwell’s 
office (BRF 137D) in a locked cabinet, in her locked office. There is also an anteroom to 
the office that remains locked. 
Each patient will be assigned a code at time of enrollment (ie: HRV1, HRV2). This 
will allow for de-identification of the patient. As protected health information and 
identifying information will be collected, this de-identification will allow for added 
confidentiality. The date of birth and medical record number will be the identifying 
information that is removed from the data collection once the study ID is assigned, and the 
medical chart has been reviewed for the additional information (see attached excel file for 
additional information that will be collected). The electronic link between the study ID and 
the patient identifiers will be kept on a password protected computer in a locked office in 
Dr. Maxwell’s office. This will not be stored in the same computer folder as any other 
documents pertaining to this study (it will be separated from the data). If the research team 
needs any of the patient information, they will be required to utilize the computer in Dr. 
Maxwell’s office. No sensitive information will be collected, and a certificate of 
confidentiality is not required. As this is a single site study, there will be no transfer of the 
data required. All data will be electronically collected and stored. All data will be kept per 
the policy HSC-R-801 PR.1, in which research records of minors (under 18 years) must be 
retained until the minor turns 22 years old; thus, all data will be stored until the youngest 
participant has reached 22 years of age.  
 
17. Data and Specimen Banking- N/A 
 
18. Risks to Subjects 
We expect the risks to the subjects to be minimal in relation to the AcqKnowledge 
heart rate variability device. The primary risk to the subjects will be skin irritation from 
the electrode placements. However, this gestational age group at baseline is at high risk 

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of complications including death, severe brain injury, necrotizing enterocolitis, chronic 
lung disease, retinopathy of prematurity and sepsis. 
 
The risks that may be present related to the AcqKnowledge HRV device include 
erythema and irritation of the skin follow electrode lead placement and removal. We will 
use gel to reduce the risk of skin irritation and gently remove the sensors using massage oil 
following the end of a skin-to-skin session to decrease discomfort during the process. 
As protected health information will be gathered, there is the risk for loss of privacy 
and/or confidentiality. We will minimize these risks by giving each participant a study ID 
and removing the identifiers at that time. Per policy, records of participants under the age 
of 18 years must be stored until the youngest participant receives 22 years of age. All 
records will be stored either electronically on Dr. Maxwell’s UNM issued password 
protected computer that is stored in her locked office, or paper copies will be stored in a 
locked cabinet in Dr. Maxwell’s office in BRF137D. 
Additionally, there is the possibility of unforeseen risks. Any concerns or SAE from 
the study will be reported to the IRB immediately. 
 
19. Potential Benefits to Subjects 
It is unknown if infants participating will benefit from skin to skin contact. However, 
infants in this study may benefit from increased skin-to-skin time with their mother or 
father. The benefit of this project will potentially be for this patient population (extremely 
preterm infants) to have increased skin-to-skin contact with their caregivers. Currently, 
some facilities across the country are less likely to support or promote skin-to-skin in 
extremely preterm infants, especially if they are intubated. However, there is benefit in this 
bonding as described previously. Therefore, the results of this study may reveal the 
importance of promoting skin-to-skin whenever possible in this high-risk population.  
 
20. Recruitment Methods 
Any infant that meets the inclusion / exclusion criteria will be considered for 
enrollment. The mother will be approached by one of the study personnel that are included 
on this IRB, and the study will be discussed if they are interested in the study. The consent 
form has been included to show what the study personnel would verbally state to the 
mother. The mother may be approached at the infant’s bedside or in her hospital room after 
delivery. If approached at the infant’s bedside, the mother will be given the option to go 
into a family room to discuss the study further for additional privacy. The Powerchart 
census will be reviewed daily to monitor for admission of infants that would meet criteria. 
There will be no additional recruitment materials used for this study. 
 
21. Provisions to Protect the Privacy Interests of Subjects 
To protect the privacy of the subjects in this study, consent will be obtained in the 
mother’s hospital room if possible. However, if the mother is present at the bedside in the 
NICU, they will be approached and asked if the study can be discussed in a private location 
(utilizing a family room or conference room) or at the bedside if the mother desires. If the 

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mother states they do not want to participate in a study, they will be informed that the infant 
will continue to receive all appropriate medical care.  
 
22. Economic Burden to Subjects 
There is no expected economic burden to the subject. Participation in the study will 
result in an added mode of monitoring, at no cost to the subject. The information collected 
from the medical record will be obtained through electronic medical record access. There 
are no samples that will be obtained, and no cost expected to the participants or a 3rd party 
payer. 
 
23. Compensation 
A Clincard in the amount of $10 will be provided to the mother or father for each skin-
to-skin session completed, with a maximum of six sessions for each participant.  
 
24. Compensation for Research-Related Injury 
As this technology is used routinely in some NICUs, the study is not expected to be 
more than minimal risk. Therefore, no research-related injury is expected to occur, and no 
compensation will be offered. 
 
25. Consent Process 
Investigators included on the IRB protocol will be responsible for obtaining consent, 
and include Dr. Maxwell, Dr. Watterberg and Dr. Swieter.  
The consent process will take place in the mother’s hospital room if possible, to allow 
for privacy. The consent process can also take place in a family room in the NICU; the 
consent would only be obtained at the infant’s bedside if the mother requested the 
conversation to occur in that location. It will be stated during the consent process that 
participation is voluntary and will have no impact on the infant’s medical care or treatment 
to minimize the possibility of coercion or undue influence. Once the study has been 
described (using the consent script that has been attached), the mother will be offered 
additional time to consider participation in the study. The mother will be contacted during 
the study period to ensure they continue to consent to the study. During the consent process, 
it will be requested that the mother is able to describe the study with the sensor placement 
to ensure understanding. 
As this study does not involve greater than minimal risk, one parent is able to give 
consent. This study involves neonates, so they will not be able to provide assent. Consent 
will be obtained for all neonates participating in the study. 
Mothers or fathers are able to hold the infant while data is collected during the study. 
Only the gender of the individual completing the skin to skin session will be obtained from 
the caregiver. Detailed information will be collected from the infant’s medical record. 
Therefore, consent will be obtained for the infant to participate, but consent will not be 
needed for the parent to hold the infant. 
 
26. Documentation of Consent 
We will use a consent form that is modified from the HRPO website. It has been 
attached for review. The signed consent forms will be stored in a locked cabinet in Dr. 

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Maxwell’s office, which is locked and has an anteroom that is locked during non-business 
hours. We will obtain consent from the mother by providing a written document that will 
be signed (attached). The study personnel obtaining consent will use the detailed consent 
form (attached). 
 
27. Study Test Results/Incidental Findings 
Test results will not be specifically shared with the participant’s families; however, 
they will be able to see the monitor and the readings while at the bedside. If at any time 
there are significant clinical changes in the infant during a session, the study will be 
stopped, and families will be notified immediately at the bedside.  
The infant will still have all routine monitoring in place with the heart rate variability 
monitor in addition. As continuous cardiac monitoring occurs as standard of care, we do 
not expect any incidental findings.  
 
28. Sharing Study Progress or Results with Subjects 
There will not be a summary of the trial progress provided while the study is underway. 
Also, there will not be a summary of the study results after the study is complete. 
29. Inclusion of Vulnerable Populations 
This study will include the vulnerable population of neonates. As some of the neonates 
will be uncertain viability (using the federal research regulations which states “viable, as it 
pertains to the neonate, means being able, after delivery, to survive (given the benefit of 
available medical therapy) to the point of independently maintaining heartbeat and 
respiration) due to continued need for ventilatory support to maintain respiration, that 
checklist has been completed. 
The population proposed in this study is necessary, as they are the population that has 
the potential to achieve benefit from this study.  
 
30. Community-Based Participatory Research –N/A 
 
31. Research Involving American Indian/Native Populations 
This study will not exclude American Indian / Native populations, nor will it target the 
population for inclusion. If a woman and infant otherwise meet criteria, they will be 
approached for consent.  
 
32. Transnational Research –N/A 
 
33. Drugs or Devices 
The device that will be used is approved for clinical use in infants. The sensors will 
be new for each patient and discarded after use. The equipment will be cleaned with 
Clorox wipes before and after each use.   
 

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34. Principal Investigator’s Assurance 
By submitting this study in the Huron IRB system, the principal investigator of this study 
confirms that: 
☒ The information supplied in this form and attachments are complete and correct.   
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements.  
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including: 
1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as RedCap. 
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include if 
the data is entered or stored using an untrusted device or storage. 
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more 
of following safeguards: access logs, encryption keys, backups, business 
continuity and disaster recovery capabilities. 
4. Alternate storage media must be approved by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards. 
 
 

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35. CHECKLIST SECTION 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research. 
36. Partial Waiver of HIPAA Authorization for Screening/Recruitment 
Complete the following additional questions/attestations if the records you will review to identify 
potential subjects and/or determine eligibility include Protected Health Information (PHI). 
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility? 
            ☒ Yes. Describe: The study team will review the medical records of infants admitted to 
the newborn intensive care unit to determine which infants may qualify for the study. This will 
look at the following items: 
Inclusion Criteria: 
• Infant must be ≤30 weeks gestational age at time of delivery. 
• Infants inborn and outborn are eligible for this study. 
• Infants must have had a head ultrasound with results showing no severe intraventricular 
hemorrhage (IVH Grade III or IV). 
• Infants must be receiving respiratory support including mechanical ventilation, 
noninvasive positive pressure ventilation (NIPPV), continuous positive airway pressure 
(CPAP), high flow nasal cannula (HFNC), or low flow nasal cannula (LFNC) at the time 
of the first session. 
• Consenting mother of the infant must speak English 
• Biological or legal adoptive fathers of the infant are eligible to complete skin to skin 
sessions with the infant   
• Infants of employees are eligible to participate. Undue influence or coercion will not be 
applied to infants of employees and participation or lack thereof will not affect employment 
status. 
Exclusion Criteria: 
• Infants who have not received a head ultrasound. 
• Infants with grade III or IV intraventricular hemorrhage identified on head ultrasound. 
• Infants on high frequency ventilation due to the artifact obtained on ECG. 
• Infants with known genetic disorders or known prenatal chromosomal anomalies. 
• Infants with one or more major congenital anomaly. 
• Infants undergoing active sepsis evaluation or treatment for infection. 
• Infants on blood pressure or cardiac medications or infusions including inotropic 
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• Mothers that are <18 years of age will not be approached for consent. 
• Mothers who are unable to provide consent due to having a legal representative will not 
be approached for consent in this study 
• Mothers who are prisoners as participation in the study requires multiple skin to skin 
sessions with the infant. 
If the infant is found to meet inclusion criteria, the study personnel will then approach the 
mother for consent. 
            ☐ No 
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the research) 
or provide justification for why they must be retained: 
The identifying information will be separated from the rest of the study data once a patient is 
consented for participation. At that time, the participant will be given a study ID, and the 
identifiers will be removed. The link for the study ID and identifiers will be kept on Dr. Maxwell’s 
UNM issue password protected computer, stored in her locked office with a locked anteroom. 
Upon completion of the study, all data will be stored per policy until the youngest participant 
reaches age 22 years. All identifying information will be destroyed upon completion of the study.  
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule. 
 
      ☒ True 
            ☐ False 
37. Waiver of Documentation of Consent N/A 
A. Are you requesting a waiver of documentation of consent for some or all 
subjects? No 
B. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form? 
☒No 
38. Alteration of Consent- N/A 
Note: FDA-regulated research is not eligible for an alteration of consent. 
39. Full Waiver of Consent/Parental Permission N/A 
Note: FDA-regulated research is not eligible for a full waiver of consent using these criteria.  If 
you believe that your FDA-regulated research may be eligible for a waiver under another 

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mechanism, such as planned emergency research, contact the HRPO for assistance in 
determining what information to provide to the HRRC. 
40. Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs) N/A 
 
41. Full Waiver of HIPAA Authorization (Checklist)- N/A 
 
42. Other Waiver Types (Checklist) N/A 
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver of 
Parental Permission to Protect Child Participants, Enforcement Discretion for In Vitro 
Diagnostics, etc. contact the HRPO office for assistance in determining what information to 
submit for the HRRC’s consideration. 
 
43. Vulnerable Populations (Checklist) 
 
A. Adults with Cognitive Impairments – N/A 
 
B. Children 
Complete this checklist if the subject population will include children. 
1. Select the category of research that you believe this research falls within and 
provide justification for any associated criteria.  If there are different 
assessments for different groups of children or arms (e.g., placebo vs. drug), 
include a memo to provide an assessment for each group.   
☒Research not involving greater than minimal risk. (Minimal risk means 
that the probability and magnitude of harm or discomfort anticipated 
in the research are not greater in and of themselves than those 
ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.) 
☐Research involving greater than minimal risk but presenting the 
prospect of direct benefit to the individual subjects. 
Provide justification for each of the following criteria: 
(1) The risk is justified by the anticipated benefit to the subjects: 
      
(2) The relation of the anticipated benefit to the risk is at least as 
favorable to the subjects as that presented by available 
alternative approaches: 

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☐Research involving greater than minimal risk and no prospect of direct 
benefit to individual subjects, but likely to yield generalizable 
knowledge about the subject's disorder or condition. 
Provide justification for each of the following criteria: 
(1) The risk represents a minor increase over minimal risk: 
      
(2) The intervention or procedure presents experiences to subjects 
that are reasonably commensurate with those inherent in their 
actual or expected medical, dental, psychological, social, or 
educational situations: 
      
(3) The intervention or procedure is likely to yield generalizable 
knowledge about the subjects' disorder or condition which is of 
vital importance for the understanding or amelioration of the 
subjects' disorder or condition 
      
C. Pregnant Women and Fetuses N/A 
 
D. Neonates of Uncertain Viability or Nonviable Neonates  
Complete this checklist if the subject population will include neonates of uncertain 
viability. 
Provide justification for each of the following: 
1. Where scientifically appropriate, preclinical and clinical studies have been 
conducted and provide data for assessing potential risks to neonates. 
Prior research has been conducted assessing heart rate variability in preterm 
infants as well as skin to skin in preterm intubated infants. There have been 
minimal risks noted to the neonates that have the heart rate variability leads 
and pneumogram in place.  
2. Each individual providing consent is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate. 
Each mother will provide consent and be fully informed. We expect there to be 
no direct benefit to the neonates in the study, however the results may inform 
future use in the NICU that may become routine. 

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3. Individuals engaged in the research will have no part in determining the 
viability of a neonate. 
The use of this technology will not impact the viability of the neonate, and the 
research team will not be determining the viability of the neonate in relation to 
this study. 
4. The research holds out the prospect of enhancing the probability of survival of 
the neonate to the point of viability, and any risk is the least possible for 
achieving that objective, or, the purpose of the research is the development of 
important biomedical knowledge which cannot be obtained by other means 
and there will be no added risk to the neonate resulting from the research 
The results of this study have the potential to increase the utilization of skin to 
skin care in preterm infants requiring ventilator support. The purpose of this 
research cannot be obtained by other means and there will be no added risk to 
the neonate resulting from this research.  
E. Nonviable Neonates N/A 
 
F. Biomedical and Behavioral Research Involving Prisoners N/A 
 
44. Medical Devices (Checklist)  - N/A 
Complete this checklist if the research evaluates the safety or effectiveness of a medical device.  
If more than one medical device is being evaluated, provide the requested information for each. 
A. Device Name:        
B. Manufacturer:        
C. Does the research involve a Significant Risk Device under an IDE? 
☐Yes. Include documentation of the FDA approval of the IDE with your submission.  
Acceptable methods of documentation include: (1) FDA letter noting IDE number 
and approval status; (2) Industry sponsor letter noting IDE number and FDA 
approval status; or (3) FDA-approved industry sponsor protocol with IDE number 
noted  
☐No 
D. Is the research IDE-exempt? 
☐Yes. Include a FDA letter with your submission noting the determination that the 
research is IDE-exempt or a letter from the sponsor (or sponsor-investigator) 
justifying why they believe the research is IDE-exempt*.   
☐No 

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E. Does the research involve a Non-Significant Risk (NSR) Device? 
☐Yes. Include a FDA letter with your submission noting the determination that the 
research is NSR or a letter from the sponsor (or sponsor-investigator) justifying why 
they believe the research is NSR**.   
☐No 
* This FDA guidance includes a description for when a device study is exempt from the 
IDE requirements: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf  
**This FDA guidance includes information on how to differentiate between Significant 
Risk and Non-Significant Risk device studies: 
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126418.pdf  
45. Export Control (Checklist)- N/A 
Indicate if there will be export control concerns (i.e., select agents or select toxins involved in the 
project, collaboration with foreign institution or foreign nationals, publication restrictions, 
foreign travel, etc.).  If so, please upload and complete Export Control Exclusion Screening 
Form.
 
46. Data Transfer/Sharing (Checklist) (required –do not delete even if the 
answer is “No”) 
Provide all information requested if the research involves transferring/sharing of data with an 
external entity (institution, company, etc.).  
A. Will data be transferred/shared with an external entity (institution, company, etc.)?   
☐Yes 
☒No. The remainder of this section does not apply.  
B. Indicate if the data is incoming and/or outgoing:         
C. Provide the name of the entity that data will be transferred/shared with:       
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with:       
E. Who is responsible for transmission of the data?            
F. Who is responsible for receiving the data?       
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC Central IT 
Transfer is detailed on the Sponsored Projects website:            
H. For data being transferred/shared with outside locations or entities, describe the 
following: 

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• Where is data storage and how will it be maintained in a secure manner (i.e. 
encryption, password protection, use of Qualtrics or REDCap, etc)?       
• What is method in which data will be collected and stored (i.e. electronic, hard 
copy, etc)?            
• How long will the data be stored?            
• Who will have access to data?         
I.  Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that identifiers 
that MUST be removed to make health information de-identified are as follows: Names, 
All geographic subdivision smaller than a State, All elements of year (except year), 
Telephone, Fax numbers, E-mail addresses, Social Security, Medical record number, 
Health plan beneficiary, Account numbers, Certificate/license numbers, Vehicle 
identifiers and serial numbers, Device identifiers and serial numbers, Web URLs, IP 
address numbers, Biometric identifiers, full face photographic images, and Any other 
unique identifying number, characteristic or code.)            
J. If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to identify, 
contact, or locate a person (e.g., name, medical record number, etc.), are the subjects 
going to consent to or authorize the disclosure of their individually identifiable health 
information?        
a. Or is HIPAA authorization altered or waived?           
K. What is the classification of the data (de-identified, limited data set, protected health 
information, other).       
L. Does the request to transfer/share data include clinical data that belongs to the UNM 
Health Systems?       
M. Does the data to be transferred/shared include information about patients seen at external 
health system or at a third party medical provider?       
N. Is the external entity a “covered entity”?         
O. Is the data that is going to be transferred/shared owned or partially owned by another 
party or have any type of restrictions including regulatory restrictions (i.e. HIPAA, 
FERPA, etc.)?       
P. Is the data publically available? If yes, please provide details:       
Q. Does the data include information about substance abuse treatment, sexually transmitted 
diseases, genetic testing results, HIV/AIDS testing results, and/or mental health?          
 
47. Specimen Transfer/Sharing (Checklist) (required –do not delete even if the 
answer is “No”) 
Provide all requested information if the research involves transferring/sharing of specimens with 
an external entity (institution, company, etc.).  
A. Will specimens be transferred/shared with an external entity (institution, company, etc.)?  
      ☐ Yes 
☒No. The remainder of this section does not apply.  
B. Indicate if the specimens are incoming and/or outgoing:       

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C. Provide the name of the entity that specimens will be being transferred/shared with: 
      
D. Provide the contact name, email and phone number with whom specimens are being 
transferred/shared with:       
E. Who is responsible for sending out the specimens? Please note specimens cannot be sent 
out without a fully executed material transfer agreement.       
F. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement.             
G. For specimens being transferred/shared with outside locations or entities, describe the 
following: 
• Where is specimen storage and how will it be maintained in a secure manner?       
• What is method in which specimens will be collected and stored?       
• How long will the specimens be stored?       
• Who will have access to the specimens?       
References 
1. Baley, J., & COMMITTEE ON FETUS AND NEWBORN. (2015). Skin-to-Skin Care for 
Term and Preterm Infants in the Neonatal ICU. Pediatrics, 136(3), 596–599 
 
2. Bisanalli, S., Nesargi, S., Govindu, R. M., & Rao, S. P. (2019). Kangaroo Mother Care in 
Hospitalized Low Birth-Weight Infants on Respiratory Support: A Feasibility and Safety Study. 
Advances in Neonatal Care: Official Journal of the National Association of Neonatal Nurses, 
19(6), E21–E25. 
 
3. Ludington-Hoe, SM., Ferreira, C., Swinth, J., & Ceccardi, J. J. (2003). Safe criteria and 
procedure for kangaroo care with intubated preterm infants. Journal of obstetric, gynecologic, 
and neonatal nursing: JOGNN, 32(5), 579–588. 
 
4. Smith, S. L. (2003). Heart period variability of intubated very-low-birth-weight infants during 
incubator care and maternal holding. American Journal of Critical Care: An Official Publication, 
American Association of Critical-Care Nurses, 12(1), 54–64. 
 
5. Reed MJ, Robertson CE, Addison PS. Heart rate variability measurements and the prediction 
of ventricular arrhythmias. Qjm: monthly journal of the association of physicians. 
2005;98(2):87-95. 
 
6. Hon EH, Lee, ST. Electronic evaluation of the fetal heart rate variability patterns preceding 
fetal death, further observations. American journal of obstetrics and gynecology. 1963;87:814-
826. 
 
7. Souza Filho, L.F et al. (2019). Evaluation of the autonomic nervous system by analysis of 
heart rate variability in the preterm infants. BMC Cardiovascular Disorders 19 (198).  
 

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8. Fairchild, K.D. (2013). Predicitive monitoring for early detection of sepsis in neonatal ICU 
patients. Current Opinion Pediatrics, 25(2), 172-179.  
 
9. Kommers DR, Joshi R, van Pul C, et al. Features of heart rate variability capture regulatory 
changes during kangaroo care in preterm infants. Journal of pediatrics. 2017; 182:92-98. 
 
10. Papile LA, Burstein J, Burstein R, Koffler H. Incidence and evolution of subependymal and 
intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 
1978 Apr;92(4):529-34. 
 
11. Baldzer K, Dykes FD, Jones A, et al. Heart Rate Variability Analysis in Full-Term Infants: 
Spectral Indices for Study of Neonatal Cardiorespiratory Control. Ped Research. 
1989;26(3):188-195. 
 
12. Pados BF, Thoyre SM, Knafl GJ, et al. Heart Rate Variability as a Feeding Intervention 
Outcome Measure in the Preterm Infant. Adv Neonatal Care. 2017 Oct;17(5):E10-E20. 
 
13. Cong X, Ludington-Hoe, SM, McCain G, et al. Kangaroo Care Modifies Preterm Infant 
Heart Rate Variability in Response to Heel Stick Pain: Pilot Study. Early Hum Dev 2009 
Sept:85(9):561-567.