Surfactant Positive Airway Pressure and Pulse Oximetry Trial

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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 premature infants born at 24 to 27 weeks gestation. In addition, these infants within 2 hours of birth, had a special pulse oximeter placed to continuously monitor their oxygen saturation in two different target ranges (85-89% or 91-95%). This study helped determine whether or not these two management strategies affect chronic lung disease and survival of premature infants.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Center for Research Resources (NCRR); National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Pulmonary Surfactants

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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