Status:
COMPLETED
Surfactant Positive Airway Pressure and Pulse Oximetry Trial
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn, Diseases
Other Preterm Infants
Eligibility:
All Genders
24-27 years
Phase:
PHASE3
Brief Summary
This study compared the use of continuous positive airway pressure initiated at birth with the early administration of surfactant administered through a tube in the windpipe within 1 hour of birth for...
Detailed Description
Study subjects were infants of 24 0/7ths to 27 6/7th weeks at birth for which a decision has been made to provide full resuscitation as required. Infants 27 weeks or less gestation (completed weeks by...
Eligibility Criteria
Inclusion
- Infants with a minimal gestational age of 24 weeks 0 days to 27 completed weeks (up to 27 6/7ths) by best obstetrical estimate
- Infants who will receive full resuscitation as necessary, i.e., no parental request or physician decision to forego resuscitation
- Infants whose parents/legal guardians have provided consent for enrollment, or
- Infants without known major congenital malformations
Exclusion
- Any infant transported to the center after delivery
- Infants whose parents/legal guardians refuse consent
- Infants born during a time when the research apparatus/study personnel are not available
- Infants \< 24 weeks 0 days or \> 28 weeks 0 days, completed weeks of gestation
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
1316 Patients enrolled
Trial Details
Trial ID
NCT00233324
Start Date
February 1 2005
End Date
August 1 2016
Last Update
April 18 2019
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Stanford University
Palo Alto, California, United States, 94304
3
University of California at San Diego
San Diego, California, United States, 92103-8774
4
Yale University
New Haven, Connecticut, United States, 06504