Time to Accurate Heart Rate on Neonatal Outcomes

NCT04587934 | Completed Results FDA Device

• 1 other identifier: GE-EKG
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Premature Infant; Extremely Low Birth Weight; Extreme Prematurity

Keywords

electrocardiogram; Neonatal Resuscitation; resuscitation of premature infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to First Change in Fraction of Inspired Oxygen

  Birth to 10 minutes of life

• Time to First Change in Airway Pressure

  Birth to 10 minutes of life

• Time to Initiation of Positive Pressure Ventilation (PPV)

  Birth to 10 minutes of life

Other Outcomes (3)

• Time of Electrode Placement

  Birth to 10 minutes of life

• EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation

  Birth to 10 minutes of life

• Time to Rhythm Recognition

  Birth to 10 minutes of life

Study Arms (2)

iRes Warmer with ResusView

EXPERIMENTAL

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

iRes Warmer without ResusView

ACTIVE COMPARATOR

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

Interventions

iRes Warmer with ResusView DEVICE

Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age

Also known as: Panda Bed with ECG Feature

iRes Warmer with ResusView

iRes Warmer without ResusView OTHER

Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age

Also known as: Standard of Care

iRes Warmer without ResusView

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sharp HealthCare: lead
• GE Healthcare: collaborator
• Sharp Mary Birch Hospital for Women & Newborns: collaborator

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (4)

• 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.

  PMID: 29099872 BACKGROUND

• Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043.

  PMID: 32102255 BACKGROUND

• Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.

  BACKGROUND

• 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.

  PMID: 34715091 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Anup Katheria
• Organization: Sharp Healthcare

Anup.Katheria@sharp.com

858-939-4170

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 14, 2020
• Study Start: February 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: December 10, 2021
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 36 months following article publication
• Access Criteria: Data and publication are available at clinicaltrials.gov

Locations

US (1)