Delivery Room CPAP in Extremely Low Birth Weight Infants
- Conditions
- Infant, Low Birth WeightContinuous Positive Airway PressureInfant, Small for Gestational AgeInfant, PrematureBronchopulmonary DysplasiaInfant, Newborn
- Interventions
- Device: CPAP/PEEPDevice: Standard management practices
- Registration Number
- NCT01223274
- Lead Sponsor
- NICHD Neonatal Research Network
- Brief 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- Infants delivered in a specially equipped resuscitation room(s)
- <28 weeks gestational age by best obstetric estimate before delivery
- Requiring resuscitation
- No known major congenital anomalies
- Decision made not to provide full resuscitation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CPAP/PEEP Intervention 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. Control Standard management practices Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
- Primary Outcome Measures
Name Time Method Compliance with the study protocol 6 months
- Secondary Outcome Measures
Name Time Method Extent of resuscitation needed Until admission to NICU Bronchopulmonary dysplasia (BPD) 36 weeks of life Number and duration of intubation attempts Until admission to the NICU Infants who required positive pressure ventilation for resuscitation in the DR/resuscitation room Until admission to the NICU Five minute Apgar 5 minutes after birth Total duration of mechanical ventilation Until hospital discharge or 120 days of life Proportion of infants requiring surfactant 1 day of life
Trial Locations
- Locations (6)
University of California at San Diego
🇺🇸San Diego, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, 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
University of Miami
🇺🇸Miami, Florida, United States