Utilization of Near-Infrared Spectroscopy Technology to Determine Normative Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude
Phase: NA
Conditions: Prematurity; Extreme
Sponsor: University of New Mexico

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PROTOCOL TITLE: 
Utilization of Near-Infrared Spectroscopy Technology to Determine Normative 
Cerebral Regional Oxygen Saturation in a Preterm Population Born at Altitude 
PRINCIPAL INVESTIGATOR: 
Dr. Jessie Maxwell, MD 
Department of Pediatrics and Neurosciences  
Division of Neonatology  
ADMINISTRATIVE CONTACT: 
 
Name Sandra Beauman 
 
Department Pediatrics 
VERSION NUMBER: 
Version 5 
DATE: 
5/26/21 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
 
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 pilot project is not currently funded; however, we will be applying for internal funding 
to cover the cost of the NIRS leads and a NIRS monitor. IRB approval is required to apply 
for the internal funding, which is why it has not yet been received. 
CLINICAL TRIALS 
Is this a clinical trial per the NIH definition of a Clinical Trial?   
 Yes   
 No 
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 

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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 ............................................................................................................... 6 
4. 
Inclusion and Exclusion Criteria ................................................................................. 6 
5. 
Number of Subjects ..................................................................................................... 6 
6. 
Study Timelines ........................................................................................................... 7 
7. 
Study Endpoints ........................................................................................................... 7 
8. 
Research Setting .......................................................................................................... 7 
9. 
Resources Available .................................................................................................... 7 
10. 
Prior Approvals ........................................................................................................ 8 
11. 
Multi-Site Research ................................................................................................. 8 
12. 
Study Procedures ..................................................................................................... 8 
13. 
Data Analysis ......................................................................................................... 10 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 10 
15. 
Withdrawal of Subjects .......................................................................................... 10 
16. 
Data Management/Confidentiality ......................................................................... 10 
17. 
Data and Specimen Banking .................................................................................. 11 
18. 
Risks to Subjects .................................................................................................... 11 
19. 
Potential Benefits to Subjects ................................................................................ 12 
20. 
Recruitment Methods ............................................................................................. 12 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
22. 
Economic Burden to Subjects ................................................................................ 12 
23. 
Compensation ........................................................................................................ 12 
24. 
Compensation for Research-Related Injury ........................................................... 12 
25. 
Consent Process ..................................................................................................... 12 
26. 
Documentation of Consent .................................................................................... 13 
27. 
Study Test Results/Incidental Findings ................................................................. 13 
28. 
Sharing Study Progress or Results with Subjects .................................................. 13 
29. 
Inclusion of Vulnerable Populations ...................................................................... 14 
30. 
Community-Based Participatory Research ............................................................ 14 
31. 
Research Involving American Indian/Native Populations ..................................... 14 
32. 
Transnational Research .......................................................................................... 14 
33. 
Drugs or Devices .................................................................................................... 14 
34. 
Principal Investigator’s Assurance ........................................................................ 14 
35. 
CHECKLIST SECTION ........................................................................................ 16 
36. 
Partial Waiver of Consent for Screening/Recruitment .......................................... 16 
37. 
Partial Waiver of HIPAA Authorization for Screening/Recruitment .................... 17 
38. 
Waiver of Documentation of Consent .................... Error! Bookmark not defined. 
39. 
Alteration of Consent .............................................. Error! Bookmark not defined. 
40. 
Full Waiver of Consent/Parental Permission .......... Error! Bookmark not defined. 
41. 
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
 
Error! Bookmark not defined. 
42. 
Full Waiver of HIPAA Authorization (Checklist) .. Error! Bookmark not defined. 
43. 
Other Waiver Types (Checklist) ............................. Error! Bookmark not defined. 
44. 
Vulnerable Populations (Checklist) ....................................................................... 17 
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45. 
Medical Devices (Checklist) .................................................................................. 20 
46. 
Export Control (Checklist) ...................................... Error! Bookmark not defined. 
47. 
Data Transfer/Sharing (Checklist) ......................................................................... 20 
48. 
Specimen Transfer/Sharing (Checklist) ................................................................. 20 
 
 
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1. Objectives 
The objective of this study is to obtain the cerebral regional oxygen saturation (cRSO2) 
in a preterm population that is born at altitude to determine if the range of “normal” values 
is different than those obtained at sea level. We hypothesize that the cRSO2 will be lower 
than the normative values that have been previously described. As more clinical studies 
are being performed, and the use of NIRS becomes more common, it is imperative that we 
assess if other factors such as altitude must be considered prior to general implementation. 
Aim 1: We will prospectively obtain cRSO2 for the first 96 hours of life in infants born 
<32 weeks’ gestation. The data obtained will not be interrupted clinically as the clinicians 
will not be able to view the data obtained from the NIRS monitoring. 
Aim 2: Outcome measures including death, intraventricular hemorrhage, necrotizing 
enterocolitis, sepsis, duration of supplemental oxygen required, time to taking full volume 
feeds via nippling, and hospital length of stay will be collected. This will be compared with 
the infant’s average cRSO2 as well as the fluctuation in cRSO2 that was observed. This may 
provide supportive evidence for clinical use of NIRS in future trials at UNMH.  
2. Background 
Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-
invasive monitoring of oxygenation in tissue[1]. Light absorption is measured at a few 
discrete wavelengths which can provide information for the tissue oxygen saturation in 
multiple organs[2], with cerebral, renal and splanchnic oxygenation being the most 
commonly measured in neonates[1]. NIRS technology was first available in 1977, however 
different sensors and manufacturers resulted in a large range of regional oxygen saturation 
(RSO2), making it difficult to establish normative values within a specific population[1]. 
Thus, improvements in the technology has resulted in the ability to consider more clinical 
uses for the NIRS technology. 
Infants with congenital heart disease is a population in which the NIRS technology has 
been applied. The use of cerebral oximetry measurement has provided the first indication 
of a clinical problem in 23% of the procedures in which the technology was utilized[1]. 
While some initial studies have shown a negative correlation between cerebral regional 
oxygen saturation (cRSO2) and gestational age[3], routine use in the preterm infant has not 
been established. 
Infants born prematurely (<37 weeks’ gestation), and especially those born extremely 
preterm (<28 weeks’ gestation), have organs that are immature and vulnerable. There are 
fluctuations in cerebral blood flow due to limitations in autoregulation, which may be 
exacerbated by routine care of the infant[4]. Previously there was a limitation in the ability 
to monitor these changes in blood flow and saturations, however NIRS now provides the 
technology needed. There are clinical trials ongoing to assess cRSO2 immediately after 
birth in an attempt to improve outcomes[5] as well as monitoring in the first 72 hours of 
life in extremely preterm infants[4]. While these studies will likely provide support for 
applying NIRS as routine care for preterm infants, there is data lacking when infants are 
born at altitude. It is unknown if the increased altitude in places such as Albuquerque and 
Denver would result in a different range of expected values with NIRS monitoring. Thus, 
we proposed a prospective observational study in which we apply NIRS monitoring to 

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infants born <32 weeks’ gestation for the first 96 hours of life to assess the cRSO2 as well 
as outcome information for the infant.  
3. Study Design 
The study will be a prospective observational study, in which any infant consented to 
participate in the study will have the NIRS applied for the first 96 hours of life. It will be 
the goal to apply the NIRS sensors in the first 12 hours of life. All infants will have the 
same treatment if in the study, but clinicians will not be able to see the data obtained so 
that there is no clinical interpretation during this time.  
4. Inclusion and Exclusion Criteria 
Inclusion Criteria: 
• Infant must be <32 weeks’ gestational age at time of delivery. 
• Consenting mother/guardian of the infant must speak English. Other languages are 
not being included due to the need of a translator being brought into the unit, which 
adds risk to the vulnerable population. Additionally, as the time to consent is a 
narrow window, adding the complexity of getting a translator may delay the ability 
to get consent and thus make it more difficult to enroll patients.  
• Infants that require blood transfusions during the monitoring time may be included. 
Exclusion Criteria: 
• Any known cardiac anomaly or other anomaly which may impair perfusion and 
blood flow. 
• Infant born after placental abruption or concern for extreme blood loss immediately 
after birth.  
• Unable to consent the mother/guardian due to maternal health issues after 
delivering (eg requiring intubation or sedation after the delivery). 
• Mothers/guardians that are prisoners, as the study team would like to have 
continuing communication with the mother during the study period as needed. 
• Mothers/guardians that are <18 years of age will not be approached for consent. 
• Any mother/guardian that is not able to consent due to having a legal representative 
will not be approached for consent in this study.  
• Any infant that is planned to be placed for adoption  
• Infant is greater than 24 hours of age at time of consent. 
Individuals will be screened for eligibility by reviewing the Newborn Intensive Care Unit 
(NICU) census twice daily.  
Any infant that has been consented for participation and completes at least 48 hours of 
NIRS monitoring will be included in the final study sample.  
5. Number of Subjects 

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This is a single site, observational study. The goal number of patients to be recruited is 
100. A similar study that evaluated an older cohort (30 weeks’ gestation to 42 weeks’ 
gestation) was able to find significant differences with a sample size of 100[3]. Given the 
number of extremely preterm infants (<28 weeks’ gestation) born at UNMH varies from 
18-30 per year, we expect to reach goal enrollment within a 2-year period, as we are 
including up to 32 weeks’ gestation. 
6. Study Timelines 
An individual will participate in the study if the guardian consents for participation. 
The NIRS device will be applied after consent has been obtained (ideally within the first 
12 hours of life). The device will remain in place, with routine skin care management 
during care times, for the first 96 hours of life and then removed. No further interventions 
will occur during the study period. Data on relevant outcomes will be extracted from the 
hospital chart during the birth hospitalization.  
The duration of time to enroll subjects is 2 years. If the goal enrollment is reached 
sooner, then enrollment will be stopped. Upon completion of enrollment, data will then be 
analyzed. This is expected to be completed 6 months after enrollment is complete; thus, 
the study duration is expected to be 2.5 years.  
7. Study Endpoints 
The primary endpoint of the study will be upon completion of goal enrollment of 100 
infants. During the enrollment period, a safety review will be completed every 5 subjects 
to ensure there are no adverse effects from the NIRS equipment. Specifically, skin integrity 
will be assessed. Given the use of this technology in multiple other studies at this 
gestational age, this is not expected to be a common finding. However, this will be routinely 
checked. Additionally, a data safety monitoring board (consisting of neonatologist Dr. 
Maxwell and co-investigators) will review the findings every 10 infants to ensure no safety 
concerns exist; any concerning findings will be immediately reported to the IRB (please 
see section 14 for additional information).  
At this time, no exploratory endpoints are expected beyond the Aims presented. 
8. Research Setting 
The research would be conducted in the NICU at the University of New Mexico 
Hospital (UNMH). Patients would be identified after admission to the NICU. The 
application of the NIRS would 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. Novak is a neonatologist and the fellowship director for the neonatology fellowship 
at UNMH. She has experience providing care for this patient population, as well as 

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experience in education that will be crucial in ensuring that all training is completed for all 
providers involved. 
Dr. Enright is a neonatology fellow who is developing experience providing care for 
this patient population and has dedicated time reserved for research and participation in 
this project. 
Dr. Rockholt-Smith is a pediatric resident who is interested in pursuing a fellowship in 
neonatology.  
All research persons will remain up to date on CITI training, as well as be expected to 
remain updated 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 100 infants over 2 years obtainable.  
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 at <32 weeks’ gestational age and does not meet exclusion 
criteria as described above will be considered for the study. The mother/guardian must 
speak English as we do not have the resources to translate the documents, nor could we 
obtain consent appropriately. If an infant is born at another hospital and transferred to 
UNMH, they will be considered for the study only if the mother/guardian is physically 
present. 
The study will be described following the consent script (attached) and if consent is 
obtained, the infant will then be given a study identifier (ex. NIRS-1). The “NIRS-1” 
component of the identifier will be the infant’s number used so that identifying information 
can be removed. For sub-analysis, the infants will be divided into 3 groups to assess the 
impact of gestational age on the measurements. Specifically, the 3 groups will be divided 
into the following ages: Group 1: 23 to £26 weeks’ gestation; Group 2: >26 weeks’ 
gestation to £29 weeks’ gestation; Group 3: >29 weeks’ gestation to 31 6/7 weeks’ 
gestation.  
The NIRS device will be applied after the infant is admitted to the Newborn Intensive 
Care Unit (NICU) at UNMH (ideally within the first 12 hours of life). The device will 
remain in place, with routine skin care management during care times, for the first 96 hours 
of life and then removed. This will allow 72-96 hours of data collection, depending on the 
timing of the placement of the NIRS device in relation to the birth time. The SpO2 (routine 
oxygen saturation monitoring) information will be collected at the same time so that the 
relative cerebral fractional tissue oxygen extraction can be calculated. The data output will 
not be visible to the clinical team, so there will not be any incidental clinical interpretation 
of this data. 
To apply the devise, a trimmed piece of Mepitel (MoInlycke), which is a translucent 
skin dressing, will be placed with the hydrocolloid adhesive-backed NIRS sensor placed 

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directly onto the Mepitel. The sensor will then be placed with the skin dressing onto the 
central forehead of the infant. The sensor will be plugged in to ensure that signal strength 
is appropriate. There will be daily inspection of the sensor site by the research team, with 
the area monitored by the bedside nurse with each care-time (usually every 3 hours). The 
area will be monitored for erythema or irritation of the skin around the sensor, and the 
sensor will be removed or replaced if necessary. We will avoid lifting up the sensor unless 
necessary for removal or repositioning. Care will be taken to avoid pressure on top of the 
sensor. After the infant is 96 hours of age, the sensor will be removed. Adhesive remover 
or a warm moist cloth will be used to slowly remove the sensor from the skin. The sensor 
will then be discarded after use. The NIRS probe (circled in red) is shown below in this 
sample image taken from van Bel, et al[6]. Additionally, the NIRS probe is plugged into a 
NIRS monitor, which is then plugged into the Phillips monitor if desired. We currently 
have 6 of the devices which connect the NIRS to the Phillips monitor, however need to 
purchase the NIRS monitor and the NIRS probes. 
 
Information will be collected from the medical record at time of enrollment as well as 
at the time of infant discharge. This information will include: gestational age at birth, birth 
weight, mode of delivery, sex of infant, maternal complications during pregnancy 
(including pre-eclampsia, chorioamnionitis, hypertension, diabetes, thyroid disease, and 
cervical insufficiency), maternal medications during pregnancy, resuscitation required at 
birth including if chest compressions were done, length and type of respiratory support 
infant required, intraventricular hemorrhage, necrotizing enterocolitis, patent ductus 
arteriosus and if treatment was used, chronic lung disease, retinopathy of prematurity, any 
surgeries that were completed during the hospitalization, sepsis, hospital length of stay, 
time to full volume nippling of feeds, and death if applicable. The data obtained during the 
NIRS recording will be collected and analyzed to determine the average cerebral regional 
oxygen saturation. The relative cerebral fractional tissue oxygen extraction will be 
calculated. The blood pressure and heart rates of each infant that are normally obtained for 
clinical purposes will be extracted from the patient charts during the time of the NIRS 
monitoring.  

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13. Data Analysis 
The cerebral regional oxygen saturation data will be averaged for each infant. All male 
and female data will be analyzed separately and the compared to determine any statistical 
differences that are present between sexes. NIRS parameters will be summarized as median 
and interquartile ranges. The relative cerebral fractional tissue oxygen extraction will be 
calculated using the following equation: (SpO2 – rScO2)/SpO2.  
As described above, there will be a sub-analysis of the infants enrolled based on 
gestational age. Specifically, the 3 groups will be divided into the following ages: Group 
1: 23 to £26 weeks’ gestation; Group 2: >26 weeks’ gestation to £29 weeks’ gestation; 
Group 3: >29 weeks’ gestation to 31 6/7 weeks’ gestation. Comparisons among different 
groups will be analyzed by one-way ANOVA followed by Dunn’s method. Categorical 
data will be analyzed using Fisher’s test. Spearman’s rank correlation coefficient will be 
used to calculate correlations between cerebral regional oxygen saturation, relative cerebral 
fractional tissue oxygen extraction and gestational age. Values of p<0.05 will be considered 
statistically significant.  
 
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, however, 
given that the patient population is at high risk for adverse outcomes, the information 
collected on each patient will be reviewed each time 10 patients have completed the NIRS 
component of the study. The neonatologists involved in the study, Dr. Maxwell, Dr. 
Zamora and Dr. Novak, will review the data. They will also review the scientific literature 
at these meetings to ensure that the study protocol remains appropriate for this patient 
population. Any concerns or SAEs will be reported to the IRB immediately.     
15. Withdrawal of Subjects 
If at any time there are concerns that the NIRS is interfering with routine care (although 
not expected to occur), the subject will be withdrawn from the research without their 
consent. If withdrawal from the study needs to occur, the NIRS equipment will be removed 
and any data collected to that point will be utilized. Collection of information will be 
obtained from the medical record as previously described, even if the NIRS monitoring is 
discontinued early. A subject can voluntarily withdrawal at any time from the study with 
no consequence or change in routine medical management. If a parent decides to withdraw 
the participant from the study, then any data that has already been collected will be kept 
for analysis (unless the PI is contacted as described in the next sentence). If the parent / 
guardian wishes to remove the data collected, then they can contact the PI , Dr. Maxwell, 
at 630-864-9422 to request all data to be removed and it will be removed. No additional 
data will be collected. 
16. Data Management/Confidentiality 
All data will be kept on a password protected computer in Dr. Maxwell’s office (BRF 
137D), which has a locked office door and a locked ante-room door. All paper records will 
be kept in a locked cabinet in Dr. Maxwell’s office (BRF 137D), which has a locked office 
door and a locked ante-room door. All electronic data will be de-identified as soon as 

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possible with identifying information destroyed. 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. 
Each patient will be assigned a code at time of enrollment (NIRS-1, NIRS-2, etc). 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 Dr. Maxwell’s UNM issued computer, which is 
password protected. This is stored in her locked office, which also has a locked anteroom. 
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. The data 
will not be publicly available unless requested with publication. 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. REDCap will be used to maintain the 
data in a secured manner. 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 NIRS device. The 
infants in this study, particularly in group 1, are at high risk of serious adverse events not 
related to NIRS. Specifically, this gestational age group is at high risk of death, severe 
brain injury, necrotizing enterocolitis, chronic lung disease, retinopathy of prematurity and 
sepsis. These will be included as outcome measures for the assessment, but the presence of 
any of these conditions would not be related to the use of NIRS.  
The risks that may be present related to NIRS sensor placement include erythema and 
irritation of the skin around the sensor. If this is noted, the sensor will be removed. If the 
area appears to have erythema and/or irritation after removal, no sensor will be replaced, 
and the data collected to that point will be used in analysis. We will use adhesive remover 
or a warm moist cloth to gently remove the sensor to avoid any discomfort during this 
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.  

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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 
The infants in this study will likely not receive direct benefit from this study. The 
benefit of this project will potentially be for extremely preterm infants that are born at 
UNMH in the future. The information obtained from this study will likely result in 
information that would allow the routine use of NIRS in infants born preterm. The infants 
in this study will likely not receive direct benefit from this study. 
20. Recruitment Methods 
Any infant that meets the inclusion / exclusion criteria will be considered for 
enrollment. The mother / guardian 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 script has been included to show what the study personnel would verbally state 
to the mother / guardian. The mother / guardian may be approached at the infant’s bedside 
or in her hospital room. If approached at the infant’s bedside, the mother / guardian 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 twice 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 / guardian 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 
/ guardian desires. If the mother / guardian 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 
and consent for use of NIRS will not be obtained.  
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 
No compensation will be provided to infants and the mothers/guardians in the study. 
 
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.  
 

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25. Consent Process 
Investigators included on the IRB protocol will be responsible for obtaining consent, 
and include Dr. Maxwell, Dr. Zamora and Dr. Novak. All are neonatologists with extensive 
experience in caring for this patient population as well as participating in clinical research 
studies. 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 that mother / guardian 
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 / guardian will 
be offered additional time to consider participation in the study. As the goal is to place the 
sensors within 12 hours of life, the time to consider will be dependent on the infant’s age 
at time of initial discussion. The mother / guardian 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 / guardian 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. If there is a guardian in place, that one guardian would be required to provide 
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. A partial waiver or alteration of 
consent is being requested in order to review the medical records to determine which 
infants may qualify for participation in the study. 
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. 
Maxwell’s office, which is locked and has an ante-room that is locked in non-business 
hours. We will obtain consent from the mother / guardian by providing them a written 
document that will be signed (attached). The study personnel that is obtaining consent will 
use the consent script to guide the review of the study (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 results which support or do not support the use of the NIRS, the study 
will be stopped, and families will be notified immediately.  
The infant will still have all routine monitoring in place with the NIRS being an 
additional tool. As the NIRS is a means of continuous, non-invasive monitoring of 
oxygenation in tissue, and the infant will have the pulse oximeter in place as part of routine 
monitoring, 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. 

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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 an approved NIRS for clinical use in infants. The sensors 
will be new for each patient and discarded after use. The sensors have a hydrocolloid 
adhesive-backing, and they will be placed on a translucent skin dressing. Mepitel 
(MoInlycke) will be used as a protective barrier for the skin. 
 
34. Principal Investigator’s Assurance 
By submitting this study in the Click 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. 

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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 approve 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 Consent for Screening/Recruitment 
Complete this checklist if you are requesting a partial waiver of consent so that you can review 
private information to identify potential subjects and/or determine eligibility prior to 
approaching potential subjects for consent or parental permission. 
A. Describe the data source that you need to review (e.g., medical records): 
The medical records for the NICU census will need to be reviewed twice daily to monitor for 
infants that meet inclusion criteria. The partial waiver of consent is to identify the patients that 
could be included in the study.  
B. Describe the purpose for the review (e.g., screening): 
The purpose of the review is to identify the gestational age of the infant and the time of birth. 
This will allow for the initial screening. The additional screening will then be completed to 
determine if the infant meets inclusion criteria. 
C. Describe who will conducting the reviews (e.g., investigators, research staff): 
Only the investigators included on this proposal will be conducting the reviews. 
D. Do all persons who will be conducting the reviews already have permitted access to the 
data source? 
 
      
 Yes 
            
 No. Explain:       
i. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria: 
1. The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above. 
 True 
 Other justification:       
2. The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline.  Further, 
the information accessed during the records review will not be 
disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility). 

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 True 
 Other justification:       
3. The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research.   
 True 
 Other justification:       
4. Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.) 
 True 
 Other justification:       
37. 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 the infants admitted 
to the newborn intensive care unit to determine which infants may qualify for the study. This will 
include looking at the following items: 
Inclusion Criteria: 
• Infant must be <32 weeks’ gestational age at time of delivery. 
• Consenting mother/guardian of the infant must speak English. 
• Infants that require blood transfusions during the monitoring time may be included. 
Exclusion Criteria: 
• Any known cardiac anomaly or other anomaly which may impair perfusion and blood flow. 
• Infant born after placental abruption or concern for extreme blood loss immediately after 
birth.  
• Unable to consent the mother/guardian due to maternal health issues after delivering (eg 
requiring intubation or sedation after the delivery). 
• Mothers/guardians that are prisoners, as the study team would like to have continuing 
communication with the mother during the study period as needed. 

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• Mothers/guardians that are <18 years of age will not be approached for consent. 
• Any mother/guardian that is not able to consent due to having a legal representative will 
not be approached for consent in this study.  
• Any infant that is planned to be placed for adoption  
• Infant is greater than 24 hours of age at time of consent. 
If the infant is found to meet inclusion criteria, the study personnel will then approach the 
mother / guardian 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 
38. Vulnerable Populations (Checklist) 
A. 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.) 
B. Neonates of Uncertain Viability or Nonviable Neonates 

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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 using the NIRS technology in this patient 
population. There have been minimal risks noted to the neonates that have the 
sensor in place. However, the use of this technology has not been reported at 
high altitude, which has the potential to directly impact the results. 
2. Each individual providing consent is fully informed regarding the reasonably 
foreseeable impact of the research on the neonate. 
Each mother / guardian 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. 
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 from this study have the potential to impact the routine use of this 
technology in the NICU and may have the ability to note if/when an infant is 
having an acute change in cerebral blood flow which may reflect an 
intraventricular hemorrhage. The purpose of this research cannot be obtained 
by other means and there will be no added risk to the neonate resulting from 
the research. 
Verify each of the following: 
1. The research will not terminate the heartbeat or respiration of the neonate 
 True 
 False 
2. There will be no added risk to the neonate resulting from the research 
 True 

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 False 
 
39. 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. 
40. Data Transfer/Sharing (Checklist) 
Complete this checklist 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.  
41. Specimen Transfer/Sharing (Checklist) 
Complete this checklist 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.  
 
References 
1. 
Sood, B.G., K. McLaughlin, and J. Cortez, Near-infrared spectroscopy: applications in 
neonates. Semin Fetal Neonatal Med, 2015. 20(3): p. 164-72. 
2. 
Kewin, M., et al., Evaluation of hyperspectral NIRS for quantitative measurements of 
tissue oxygen saturation by comparison to time-resolved NIRS. Biomed Opt Express, 
2019. 10(9): p. 4789-4802. 
3. 
Tina, L.G., et al., Near Infrared Spectroscopy in healthy preterm and term newborns: 
correlation with gestational age and standard monitoring parameters. Curr Neurovasc 
Res, 2009. 6(3): p. 148-54. 
4. 
Hansen, M.L., et al., Cerebral near-infrared spectroscopy monitoring versus treatment as 
usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical 
phase III trial. Trials, 2019. 20(1): p. 811. 
5. 
Pichler, G., et al., Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery 
in preterm neonates during immediate transition after birth (COSGOD III): an 
investigator-initiated, randomized, multi-center, multi-national, clinical trial on 
additional cerebral tissue oxygen saturation monitoring combined with defined treatment 
guidelines versus standard monitoring and treatment as usual in premature infants 
during immediate transition: study protocol for a randomized controlled trial. Trials, 
2019. 20(1): p. 178. 
6. 
van Bel, F. and J.P. Mintzer, Monitoring cerebral oxygenation of the immature brain: a 
neuroprotective strategy? Pediatr Res, 2018. 84(2): p. 159-164. 

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