A Phase 1/2 interventional study of CPAP/PEEP and Standard management practices in Infant, Newborn, Infant, Low Birth Weight and Infant, Small for Gestational Age, sponsored by NICHD Neonatal Research Network. Completed at 6 sites in United States. Open to participants aged Up to 10 Minutes. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by NICHD Neonatal Research Network · Phase 1/2, Interventional, and Treatment
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).
Previous studies suggested that early continuous airway positive pressure (CPAP) may be beneficial in reducing ventilator dependence and subsequent bronchopulmonary dysplasia (BPD) in extremely low birth weight (ELBW) infants. These studies did not test for the optimal timing of CPAP initiation or compare CPAP/PEEP initiation in the delivery room against standard resuscitation methods. Current practice at the time was for the ELBW infant to be intubated early and administered prophylactic surfactant. The feasibility of initiating CPAP in the DR and continuing this therapy without intubation for surfactant had not been determined prospectively in a population of ELBW infants.
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).
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This study's enrollment of 104 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
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: CPAP/PEEP
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Device: Standard management practices
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.
Also known as: Neopuff
Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
Compliance with the study protocol
Time frame: 6 months
Extent of resuscitation needed
Time frame: Until admission to NICU
Five minute Apgar
Time frame: 5 minutes after birth
Total duration of mechanical ventilation
Time frame: Until hospital discharge or 120 days of life
Proportion of infants requiring surfactant
Time frame: 1 day of life
Bronchopulmonary dysplasia (BPD)
Time frame: 36 weeks of life
Number and duration of intubation attempts
Time frame: Until admission to the NICU
Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room
Time frame: Until admission to the NICU
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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NICHD Neonatal Research Network