Overview

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