Delivery Room CPAP in Extremely Low Birth Weight Infants

Completed · Phase 1/Phase 2

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure

In brief

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).

Key facts

Study ID

NCT01223274

Run by

NICHD Neonatal Research Network

People needed

104

Starts

2002-07-01

Expected to finish

2003-01-01

Last updated by the study team

2026-07-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants delivered in a specially equipped resuscitation room(s)
• <28 weeks gestational age by best obstetric estimate before delivery
• Requiring resuscitation

You may not qualify if…

• No known major congenital anomalies
• Decision made not to provide full resuscitation

Where it is running

• 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

Full record on ClinicalTrials.gov

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