Surfactant Positive Airway Pressure and Pulse Oximetry Trial

Completed · Phase 3

Conditions studied: Infant, Newborn, Diseases, Other Preterm Infants, Infant, Small for Gestational Age, Premature Birth, Bronchopulmonary Dysplasia, Retinopathy of Prematurity

In brief

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.

Key facts

Study ID

NCT00233324

Run by

NICHD Neonatal Research Network

People needed

1316

Starts

2005-02-01

Expected to finish

2016-08-01

Last updated by the study team

2019-04-18

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• University of California at San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest University — Charlotte, North Carolina, United States
• RTI International — Durham, North Carolina, United States
• Duke University — 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
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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