Surfactant Positive Airway Pressure and Pulse Oximetry Trial

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.

Conditions

• Infant, Newborn, Diseases
• Other Preterm Infants
• Infant, Small for Gestational Age
• Premature Birth
• Bronchopulmonary Dysplasia
• Retinopathy 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• National Center for Research Resources (NCRR)

  collaborator NIH

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

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N. Goldberg, MD · Duke University

• Barbara J. Stoll, MD · Emory University

• Brenda B. Poindexter, MD MS · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P. Van Meurs, MD · Stanford University

• Ivan D. Frantz III, MD · Tufts Medical Center

• Neil N. Finer, MD · University of California, San Diego

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Edward F. Bell, MD · University of Iowa

• Kristi L. Watterberg, MD · University of New Mexico

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

• Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• Roger G. Faix, MD · University of Utah

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

24 Weeks

Max Age

27 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-02-28

Primary Completion

2009-02-28

Completion

2016-08-31

Countries

• United States

Study Locations