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Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants

NCT04413097 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-06-12

No results posted yet for this study

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).

Conditions

  • IVH- Intraventricular Hemorrhage
  • Extreme Prematurity
  • Hypoxia Neonatal
  • Hyperoxia
  • Respiratory Insufficiency

Interventions

PROCEDURE

Delayed Cord Clamping with Low Oxygen concentration

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

PROCEDURE

Delayed Cord Clamping with High Oxygen concentration

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

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • 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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
28 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2025-05-19
Completion
2026-05-31

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 NCT04413097 on ClinicalTrials.gov