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Delivery Room CPAP in Extremely Low Birth Weight Infants — DR-CPAP  

Bronchopulmonary Dysplasia Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01223274
Study type Interventional
Source NICHD Neonatal Research Network
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2002
Completion date January 2003
View Details
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