Brief Title
Delivery Room CPAP in Extremely Low Birth Weight Infants
Official Title
Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants
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).
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Compliance with the study protocol
Secondary Outcome
Extent of resuscitation needed
Condition
Infant, Newborn
Intervention
CPAP/PEEP
Study Arms / Comparison Groups
CPAP/PEEP Intervention
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
104
Start Date
July 2002
Completion Date
January 2003
Primary Completion Date
January 2003
Eligibility Criteria
Inclusion Criteria: - Infants delivered in a specially equipped resuscitation room(s) - <28 weeks gestational age by best obstetric estimate before delivery - Requiring resuscitation Exclusion Criteria: - No known major congenital anomalies - Decision made not to provide full resuscitation
Gender
All
Ages
N/A - 10 Minutes
Accepts Healthy Volunteers
No
Contacts
Neil N. Finer, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01223274
Organization ID
NICHD-NRN-0028
Secondary IDs
U10HD021364
Study Sponsor
NICHD Neonatal Research Network
Collaborators
National Center for Research Resources (NCRR)
Study Sponsor
Neil N. Finer, MD, Study Director, University of California, San Diego
Verification Date
September 2017