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Time to Accurate Heart Rate on Neonatal Outcomes

NCT04587934 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-01-10

Study results available
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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

Interventions

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

iRes Warmer without ResusView

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

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Sharp Mary Birch Hospital for Women & Newborns

    collaborator OTHER

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Anup Katheria, MD · Sharp HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
23 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-06-30
Completion
2021-12-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04587934 on ClinicalTrials.gov