NCT01223274

Delivery Room CPAP in Extremely Low Birth Weight Infants

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 10 Minutes
• Healthy volunteers: Not accepted

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).

Detailed description

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).

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-07-01
• Primary completion: 2003-01-01
• Completion: 2003-01-01
• First posted: 2010-10-18
• Last updated: 2017-09-26

Locations

6 sites across 1 country: United States