Time to Accurate Heart Rate on Neonatal Outcomes
Phase: NA
Conditions: Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
Sponsor: Sharp HealthCare

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Protocol 
Time to accurate Heart Rate on Neonatal Outcomes 
Sponsor: 
GE Healthcare 
9900 W Innovation Drive 
Wauwatosa, WI 53226 USA 
Principal Investigator:  
Anup Katheria, MD 
3003 Health Center Drive 
San Diego, CA 92123 
Purpose and Background 
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView 
and using iRes Warmer without ResusView when used in the resuscitation (e.g. CPR or breathing 
assistance) of premature newborns (23 to 32+6 weeks gestation). 
Our primary hypothesis is that the use of electrocardiogram (ECG) leads during resuscitation of 
premature infants born at 23+0 to 32+6 weeks gestational age using iRes Warmer with ResusView will 
display a heart rate within 30 sec of lead placement and allow for earlier response to low heart rate by 
clinical team during transition following delivery. We hypothesize that the use of ECG leads during 
resuscitation of premature infants born at 23+0 to 32+6 weeks gestational age using iRes Warmer 
without ResusView will display a heart rate on a standalone ECG monitor at or after 30 seconds of 
placement of leads leading to delayed intervention to low heart rate. 
Our experience with the current GE ECG standalone monitor has shown the time to pick up a heart rate 
is delayed 30-60 seconds from time of lead placement.  It has not been established whether a faster ECG 
algorithm would have an impact on neonatal resuscitation outcomes.  Therefore, we will conduct a 
randomized trial to determine whether the new algorithm would provide a heart rate sooner and have 
an impact on neonatal resuscitation of infants born at 23 to 32+6 weeks gestational age. 
The American Academy of Pediatrics Neonatal Resuscitation Program recommends the use of a cardiac 
monitor in infants that need resuscitation [1].  Previous trials have looked at how the availability of 
electrocardiogram (ECG) affects clinical interventions in the delivery room [2] and point toward the need 
for further evaluation of ECG use in preterm infants. Accurate, reliable, and fast heart rate (HR) display 
ensures interventions are delivered immediately. Ineffective HR assessment can increases the risk of 
hypoxic injury and infant mortality. [3]  Standalone ECG monitors currently in use with the iRes Warmer 
without ResusView has a delay in displaying heat rate from the time of lead placement greater than 30 
seconds from time of lead placement. [2] 

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Subjects 
40 infants delivered at 23+0 to 32+6 weeks EGA will be enrolled from Sharp Mary Birch Hospital for 
Women & Newborns. Premature newborn from 23+0 to 32+6 weeks gestation meeting inclusion 
criteria and consented prior to delivery at Sharp Mary Birch will be considered for enrollment until we 
reach our target of 40 newborns over the one-year period. This study will include subjects from a 
vulnerable population and will safeguard subjects through implementation of an augmented consent 
process with added time and simplification of consent language.  
Inclusion Criteria 
• 
Infants who are delivered to mothers 16 years of age or older 
• 
Infants delivered at 23+0 to 32+6 weeks EGA (estimated gestational age) based on the best 
obstetric estimate at the time of delivery. 
• 
Infants without known congenital malformations prior to delivery 
• 
Antenatal consent 
Exclusion Criteria 
• 
Infants who are delivered to mothers under the age of 16 years of age 
• 
Known congenital anomalies of newborn prior to delivery 
• 
Cardiac defects other than small VSD and PDA 
• 
Declined consent 
• 
iRes Warmer with ResusView not available at time of delivery 
• 
Multiples of more than two  
Methods and Procedures 
This is a prospective interventional randomized control trial. Infants born between 23 weeks and 32+6 
gestational age will be randomized using a computer generate allocation sequence stratified by 
gestational age. Randomization cards will be placed in opaque envelopes.  For the intervention group, 
the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in 
the first 10 minutes of life. During use of the iRes warmer, standard nursing care of an infant on a 
radiant warmer will be followed. Participants assigned to the control group will receive interventions 
using the same model Panda bed without ResusView and a standalone cardiac monitor.  There is no 
minimum time for monitoring, and the maximum time depends on clinical determination for use of HR 
feature for each resuscitation event. Data including the infant’s gestational age, ECG monitor type and 
activities that occurred during resuscitation will be recorded for the first 10 minutes of life.  
Currently, all infants taken to the resuscitation suite have recordings of heart rate, oxygenation, and 
airway pressure, along with simultaneous video recording. These recordings are reviewed monthly as 
part of our quality improvement process. Routine use of ECG monitoring may be used per physician 
preference. Therefore, the placement of electrodes (ECG) at the time of birth will not be an additional 
component of clinical care. Infants born between 23+0 – 32+6 weeks EGA are representative of the 
population that is expected to use the device in clinical practice.  
Primary outcome:   

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1. Time to heart rate display [Time frame: 1 minute] 
a. Time to heart rate displayed on monitor following lead placement 
Secondary outcome: 
1. Time to first change in FiO2 
a. Time to first increase or decrease in FiO2 from first heart rate display 
2. Time to first change in airway pressure 
a. Time to first increase or decrease in airway pressure from first heart rate display 
3. Time to initiation of Positive Pressure Ventilation (PPV) 
a. Time to start PPV following first heart rate display 
Exploratory Outcomes 
4. Time of electrode placement [Time frame: 0- 10minutes] 
a. Time to application of ECG electrodes from time of birth 
5. Is the rhythm recognized? [Time frame: 0- 10minutes] 
a. Is the rhythm recognized Y/N 
6. Time to rhythm recognition [Time frame: 0- 10minutes] 
a. Measure at what time the Warmer displays the baby’s cardiac rhythm 
Subject Identification, Recruitment and Informed Consent 
Pregnant women who are dated by their earliest ultrasound or last menstrual period at 23+0 – 32+6  
weeks gestation will be identified, recruited and consented from the labor and delivery floor or perinatal 
special care unit. Parents will be approached for consent prior to delivery. Recruitment of prospective 
subjects will occur through pre-screening electronic medical records from pool of inpatient mothers 
admitted at 23+0 to 32+6 EGA to Sharp Mary Birch Hospital for Women & Newborns.  
The primary investigator, a delegated sub-investigator or research associate will obtain consent prior to 
any research procedure. The mother, or legally authorized representative must sign the informed consent 
document. Mother, will sign a HIPAA authorization providing access to the child’s medical records for data 
collection purposes. The subject’s legally authorized representatives will be given ample time to read the 
informed consent, ask questions of the research team, and discuss the study with their family and/or the 
subject’s physician. The informed consent process will be documented in the electronic medical record and 
copies of the signed and dated consent will be given to the subject’s representatives, placed in the subject’s 
physical chart, and stored in a locked cabinet in the offices of the Neonatal Research Institute. 
Waiver of Informed Consent and Waiver of HIPAA Authorization for Pre-
Screening 
 
Waivers of informed consent and of HIPAA Authorization are requested for pre-screening medical records. 
The use or disclosure will not adversely affect the rights and welfare of the subjects.  This research protocol 
cannot be conducted without partial waiver because investigators would be unable to identify eligible 
subjects. This will involve no more than minimal risk to the privacy of subjects. Only research 
investigators/assistants will access PHI for eligibility and screening purposes.  
 

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PHI that will be accessed for screening will be identifiable on research-related forms by a study number.  We 
will take the following precautions to maintain the confidentiality of identifiable subject information.  We 
will also keep subject’s identity separate from their data on a Master log and coded. PHI will not be used or 
disclosed to any other person or entity, except as required by law. 
1. Paper-based records will be kept in a secure location and accessible only to persons involved in the 
study 
2. Computer-based files will be available only to persons involved in the study through the use of 
access privileges and passwords. 
3. Prior to accessing any PHI, personnel will be required to sign statements agreeing to protect the 
security and confidentiality of identifiable health information 
4. Whenever feasible, identifiers will be removed from study-related information 
5. PHI will not be disclosed or re-used for other purposes 
6. Collect only the minimum necessary subject identifiers. 
7. Limit physical access to any area or computer that contains subject identifiers. 
8. Limit electronic access to any computer that contains subject identifiers. 
9. Avoid storing subject identifiable data on portable devices (such as laptop computers, digital 
cameras, portable hard drives including flash drives, USB memory sticks, iPods or similar storage 
devices) as these devices are particularly susceptible to loss or theft. If there is a necessity to use 
portable devices for initial collection of subject identifiers, the data files must be encrypted, and 
subject identifiers transferred to a secure system as soon as possible. 
10. Remove necessary subject identifiers from data files, and encrypt data files if stored electronically. 
Identifiers will be stored in a physically separate and secure location from the data files, and 
associated with the data files through a key code that is also stored in a separate and secure 
location. 
11. Use only secure modes of transmission of data; subject identifiers submitted over a public network 
will be encrypted. 
12. Review the Information Security & Privacy website for additional recommendations on how to best 
secure confidential data. 
13. If there is an inadvertent breach of confidentiality of the research data which causes harm or places 
subjects or others at a greater risk of harm (including physical, psychological, economic, or social 
harm), the Lead Researcher will report this to the IRB through the electronic Unanticipated 
Problems reporting process within 5 working days of the researcher becoming aware of the event. 
14. Assurance that the privacy of the subject will be maintained by avoiding discussions about the 
patient within earshot of other patients or non-participants. 
 
Compensation of Subjects and Costs 
The study sponsor will provide the iRes Warmer with ResusView to Sharp Mary Birch Hospital for 
Women & Newborns at no cost for a 6 month period. There are no additional costs to study 
participants. Study Participants and health plan/insurance Company are responsible for the cost of 
participants’ hospitalization and standard clinical care provided. Participants will be responsible for co-
pays and deductibles in the same way as outside of a clinical trial. 
Data Collection and Analysis  
Study data will be maintained using REDCap data management system and managed by Sharp’s 
Neonatal Research Institute. All collected variables are listed in the CRF forms (see attached). We will 

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describe / compare baseline demographics, clinical outcome variables between the two groups using 
univariate and appropriate bivariate analysis. A future detailed statistical analysis plan will be made 
available prior to completion of the trial. 
Privacy, Confidentiality and Data Monitoring 
All SAEs will be reported within 72 hours of discovery of event, to the PI and the IRB (if applicable) at the 
Sharp Data center.  
Any Unexpected AE or Serious Deviation will be reported within 7 days of discovery of event to the 
Sharp Data Center. 
Unexpected events that are Not Serious are reported not more than 14 days after the PI first learns of 
the event. All other expected outcomes of prematurity, i.e. BPD, IVH grades 1-4, ROP, NEC will be 
collected in the electronic database and reviewed in interim reports.  
The study will meet FDA monitoring requirements by: Monitor data quality through routine review of 
submitted data to identify and follow-up on missing data, inconsistent data, data outliers, and potential 
protocol deviations that may be indicative of systemic or significant errors in data collection, study 
conduct. 
FDA Requirements for investigational devices: 
(1) The investigator will label the device in accordance with FDA regulations for investigational devices. 
(2) The investigator will comply with FDA requirements for records and reports. (3) The investigator will 
not market or promote the device. 
 
Potential Benefits 
There may or may not be direct benefits to participants in this study. We hope the information we learn 
will help babies born prematurely in the future. 
Potential Risks 
Loss of confidentiality: All data will be safeguarded in accordance with the Health Insurance Portability 
and Accountability Act (HIPAA) and the principles and practices of strict confidentiality. Data will be 
maintained by numerical code without personal identifiers. Computer-based files will be available only 
to persons involved in the study with access privileges and password protection. However, there is still a 
potential risk of loss of data and privacy. As with any study, there may be risks that currently are 
unforeseeable. 
Only research team members (with appropriate research training relevant to protection of human 
subjects) shall have access to the study’s databases. 
All risks with conducting this study are associated with prematurity including severe IVH, death, 
retinopathy of prematurity, chronic lung disease and other lung problems. There should be no more 
risks for babies in this study than are possible for any Extreme Low Birth Weight (ELBW) baby needing 
resuscitation. However, as with all research, there may be risks that are unknown at this time. 

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References 
1. 
Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of 
Pediatrics. 
2. 
Katheria, A., et al., A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS 
One, 2017. 12(11): p. e0187730. 
3. 
Johnson, P.A. and G.M. Schmölzer, Heart Rate Assessment during Neonatal Resuscitation. 
Healthcare (Basel), 2020. 8(1).