Early Surfactant to Reduce Use of Mechanical Breathing in Low Birth Weight Infants

Summary

Mechanical ventilation (MV) of preterm infants with respiratory distress syndrome (RDS) is associated with lung injury and nosocomial infection. Moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. This multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (CPAP) in infants 1,250-2,000g with RDS reduced mechanical ventilation usage without added complications. Infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of CPAP, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

Conditions

• Infant, Newborn
• Respiratory Distress Syndrome
• Respiratory Insufficiency

Interventions

DRUG

Early surfactant

Early surfactant followed by extubation within 30 minutes and application of continuous positive airway pressure (CPAP)

DRUG

Standard practice

Surfactant according to current center practice, only after initiation of mechanical ventilation.

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Edward F. Donovan, MD · Children's Hospital Medical Center, Cincinnati

• David K. Stevenson, MD · Stanford University

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

• Richard A. Ehrenkranz, MD · Yale University

• Barbara J. Stoll, MD · Emory University

• James A. Lemons, MD · Indiana University

• Charles R. Bauer, MD · University of Miami

• Lu-Ann Papile, MD · University of New Mexico

• Seetha Shankaran, MD · Wayne State University

• Avroy A. Fanaroff, MD · Case Western Reserve University, Rainbow Babies and Children's Hospital

• William Oh, MD · Brown University, Women & Infants Hospital of Rhode Island

• Sheldon B. Korones, MD · University of Tennessee

• Jon E. Tyson, MD MPH · The University of Texas Health Science Center, Houston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

12 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-05-31

Primary Completion

2002-07-31

Completion

2002-07-31

Countries

• United States

Study Locations