Clinical Trial

Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

Study acronym: DOXIE
Active, Not Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2020-05-29; most recent amendment 2025-06-09.
Status change: Recruiting → Active, Not Recruiting 2025-05-21
Status change: Not Yet Recruiting → Recruiting 2021-11-02
Trial Details
NCT Number NCT04413097
Lead Sponsor Sharp HealthCare
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Sharp Mary Birch Hospital for Women & Newborns
Conditions IVH- Intraventricular Hemorrhage, Extreme Prematurity, Hypoxia Neonatal, Hyperoxia, Respiratory Insufficiency
Enrollment 140 participants
Start Date 2021-11-17
Primary Completion 2025-05-19 (estimated)
Study Completion 2026-05-31 (estimated)
Updated on ClinicalTrials.gov 2025-06-12