Gentler resuscitation may protect fragile lungs in tiniest babies

NCT ID NCT01223274

Completed Disease control Sponsor: NICHD Neonatal Research Network Source: ClinicalTrials.gov ↗

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study tests whether using continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) during resuscitation helps extremely low birth weight infants (born before 28 weeks) breathe better and avoid lung damage. Half of the babies receive standard care with 100% oxygen alone, while the other half get oxygen plus CPAP or PEEP through a facemask. The goal is to see if this gentler approach is feasible and reduces the need for breathing tubes and long-term ventilation.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: CPAP/PEEP (continuous positive airway pressure/positive end-expiratory pressure) via Neopuff device
What this could lead to: If this approach works, it could lead to better breathing support for the tiniest newborns, potentially reducing lung injury and the need for long-term ventilation.
What could go wrong: This is an early pilot study with only 104 infants, so results may not be conclusive. The intervention may not improve outcomes and could carry risks like lung overinflation or air leaks.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia fetal growth restriction Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRONCHOPULMONARY DYSPLASIA CONTINUOUS POSITIVE AIRWAY PRESSURE INFANT, LOW BIRTH WEIGHT INFANT, NEWBORN INFANT, PREMATURE INFANT, SMALL FOR GESTATIONAL AGE

Contacts and locations

Locations

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

Cleveland, Ohio, 44106, United States
Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States
RTI International

Durham, North Carolina, 27705, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States
University of California at San Diego

San Diego, California, 92103-8774, United States
University of Miami

Miami, Florida, 33136, United States

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