Surfactant Positive Airway Pressure and Pulse Oximetry Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

1,316

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

February 28, 2009

Study Completion Date

August 31, 2016

Conditions
Infant, Newborn, DiseasesOther Preterm InfantsInfant, Small for Gestational AgePremature BirthBronchopulmonary DysplasiaRetinopathy of Prematurity
Interventions
DRUG

Surfactant

Intubation and administration of surfactant by 1 hour of age.

DEVICE

Continuous Positive Airway Pressure (CPAP)

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

DRUG

Supplemental oxygen with target saturation of 85 to 89%

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

DRUG

Supplemental oxygen with target saturation of 91 to 95%

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

Trial Locations (22)

14642

University of Rochester, Rochester

27157

Wake Forest University, Charlotte

27705

RTI International, Durham

27710

Duke University, Durham

30303

Emory University, Atlanta

33136

University of Miami, Miami

35233

University of Alabama at Birmingham, Birmingham

38163

University of Tennessee, Memphis

44106

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland

45267

Cincinnati Children's Medical Center, Cincinnati

46202

Indiana University, Indianapolis

48201

Wayne State University, Detroit

52242

University of Iowa, Iowa City

75235

University of Texas Southwestern Medical Center at Dallas, Dallas

77030

University of Texas Health Science Center at Houston, Houston

84108

University of Utah, Salt Lake City

87131

University of New Mexico, Albuquerque

94304

Stanford University, Palo Alto

92103-8774

University of California at San Diego, San Diego

06504

Yale University, New Haven

02111

Tufts Medical Center, Boston

02905

Brown University, Women & Infants Hospital of Rhode Island, Providence

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

National Center for Research Resources (NCRR)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

NICHD Neonatal Research Network

NETWORK

NCT00233324 - Surfactant Positive Airway Pressure and Pulse Oximetry Trial | Biotech Hunter | Biotech Hunter