Time to Accurate Heart Rate on Neonatal Outcomes (GE-EKG)

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. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).

Study Overview

• Status: Completed
• Conditions: Premature Infant; Extreme Prematurity; Extremely Low Birth Weight
• Intervention / Treatment: Device: iRes Warmer with ResusView; Other: iRes Warmer without ResusView

Detailed Description

This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated 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. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants who are delivered to mothers over the age of 16 years of age
• Infants delivered at 23+0 to 32+6 weeks 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 Ventricular septum defect and Patent ductus arteriosus
• Multiples
• Declined consent
• iRes Warmer with ResusView not available at time of delivery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iRes Warmer with ResusView; iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.	Device: iRes Warmer with ResusView; Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age; Other Names: Panda Bed with ECG Feature
Active Comparator: iRes Warmer without ResusView; An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.	Other: iRes Warmer without ResusView; Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age; Other Names: Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Heart Rate Display in iRes Warmer With Resusview	Measure time from birth to heart rate displayed on monitor following lead placement	Birth to 10 minutes of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Change in Fraction of Inspired Oxygen	Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement	Birth to 10 minutes of life
Time to First Change in Airway Pressure	Measure time from birth to first increase or decrease in airway pressure from ECG lead placement	Birth to 10 minutes of life
Time to Initiation of Positive Pressure Ventilation (PPV)	Measure time from birth to start of PPV following first heart rate display	Birth to 10 minutes of life

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Electrode Placement	Measure time from birth to application of Electrocardiogram electrodes from time of birth	Birth to 10 minutes of life
EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation	Identify if a cardiac rhythm is recognized by Electrocardiogram monitor algorithm and displays a waveform during resuscitation (Yes/No)	Birth to 10 minutes of life
Time to Rhythm Recognition	Measure at what time the Warmer displays the baby's cardiac rhythm	Birth to 10 minutes of life

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: GE Healthcare; Sharp Mary Birch Hospital for Women & Newborns
• Investigators: Principal Investigator: Anup Katheria, MD, Sharp HealthCare

Publications and helpful links

General Publications

• Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.
• Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043.
• Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.
• Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): December 10, 2021

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 8, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: electrocardiogram; Neonatal Resuscitation; resuscitation of premature infants
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: GE-EKG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
• IPD Sharing Time Frame: Beginning 6 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Data and publication are available at clinicaltrials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No