CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
iRes Warmer with ResusView +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04587934
NCT04587934N/ACompleted
CompareCT.gov

Time to Accurate Heart Rate on Neonatal Outcomes

Sharp HealthCare·interventional·Posted Oct 14, 2020·Updated Jan 10, 2024

In Brief

A clinical study evaluating iRes Warmer with ResusView and iRes Warmer without ResusView for Premature Infant and 2 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremature Infant, Extremely Low Birth Weight, Extreme Prematurity
CountriesUnited States
CollaboratorsGE Healthcare, Sharp Mary Birch Hospital for Women & Newborns

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 14, 2020
Enrollment StartFeb 1, 2021
Primary CompletionJun 30, 2021
Study CompletionDec 10, 2021
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.7 years ago

Interventions

iRes Warmer with ResusViewdevice

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

iRes Warmer without ResusViewother

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