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COMPLETED
NCT01223274
PHASE1/PHASE2

Delivery Room CPAP in Extremely Low Birth Weight Infants

Sponsor: NICHD Neonatal Research Network

View on ClinicalTrials.gov

Summary

This pilot study was designed to determine the feasibility of randomizing extremely low birth weight (ELBW) infants \<28 weeks' gestation who required resuscitation to one of two resuscitation methods, either: (a) 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV (the intervention group); or (b) 100% oxygen and no CPAP and no PEEP if the infant required PPV (the control group).

Official title: Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants

Key Details

Gender

All

Age Range

Any - 10 Minutes

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2002-07

Completion Date

2003-01

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

DEVICE

CPAP/PEEP

Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.

DEVICE

Standard management practices

Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.

Locations (6)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California at San Diego

San Diego, California, United States

University of Miami

Miami, Florida, United States

RTI International

Durham, North Carolina, United States

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States