At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 1,316 enrolled

Drug / intervention

Surfactant +3 moredrug

Likely dose

Surfactant administered intubated by 1 hour of age; CPAP/PEEP begun in delivery room; supplemental oxygen titrated to target saturation 85-89% or 91-95%AI-extracted

Key inclusion· 4

✓Gestational age 24 weeks 0 days to 27 completed weeks (up to 27 6/7 weeks)
✓Will receive full resuscitation as necessary (no parental request or physician decision to forego resuscitation)
✓Parental/legal guardian consent obtained
✓No known major congenital malformations

Key exclusion· 4

✕Transported to the center after delivery
✕Parental/legal guardian refusal of consent
✕Birth outside study personnel/apparatus availability
✕Gestational age <24 weeks 0 days or >27 6/7 weeks

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00233324

NCT00233324Phase 3Completed

Compare CT.gov

Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) in Extremely Low Birth Weight Infants

NICHD Neonatal Research Network·interventional·Posted Oct 5, 2005·Updated Apr 18, 2019

In Brief

A Phase 3 clinical trial evaluating Surfactant, Continuous Positive Airway Pressure (CPAP), and 2 other interventions for Infant, Newborn, Diseases and 5 related conditions. Completed, enrolled 1,316 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

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

CountriesUnited States

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Center for Research Resources (NCRR), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2005

First PostedOct 2005

Primary CompletionFeb 2009

Study CompletionAug 2016

TodayJul 2026

First PostedOct 5, 2005

Enrollment StartFeb 1, 2005

Primary CompletionFeb 1, 2009

Study CompletionAug 1, 2016

TodayJul 1, 2026

Enrollment to primary: 4 yearsPosted 20.7 years ago

Interventions

Surfactantdrug

Intubation and administration of surfactant by 1 hour of age.

Continuous Positive Airway Pressure (CPAP)device

Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU

Supplemental oxygen with target saturation of 85 to 89%drug

Supplemental oxygen in the range of 85% to 89% until the infant is no longer requiring ventilatory support or oxygen

Supplemental oxygen with target saturation of 91 to 95%drug

Supplemental oxygen in the range of 91% to 95% until the infant is no longer requiring ventilatory support or oxygen.