CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 140 enrolled
Drug / intervention
Delayed Cord Clamping with Low Oxygen concentration +1 moreprocedure
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/NCT04413097
NCT04413097N/AActive
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Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

Sharp HealthCare·interventional·Posted Jun 2, 2020·Updated Jun 12, 2025

In Brief

A clinical study evaluating Delayed Cord Clamping with Low Oxygen concentration and Delayed Cord Clamping with High Oxygen concentration for IVH- Intraventricular Hemorrhage and 4 related conditions. Active but no longer recruiting, targeting 140 participants across 3 sites.

Detailed Summary

This study is being conducted to compare the incidence of preterm infants (up to 28+6 weeks GA) who achieve a peripheral oxygen saturation of 80 percent by 5 minutes of life (MOL) given mask CPAP/PPV with an FiO2 of 1.0 during DCC for 90 seconds (HI Group) to infants given mask CPAP/PPV with an FiO2 of .30 during DCC for 90 seconds (LO Group).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia, Respiratory Insufficiency
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sharp Mary Birch Hospital for Women & Newborns

Timeline

N/AActiveOverdue
202120222023202420252026
First PostedJun 2, 2020
Enrollment StartNov 17, 2021
Primary CompletionMay 19, 2025
Study CompletionMay 31, 2026
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 6.1 years ago

Interventions

Delayed Cord Clamping with Low Oxygen concentrationprocedure

During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.

Delayed Cord Clamping with High Oxygen concentrationprocedure

During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.