Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Summary

The purpose of this study is to compare the efficacy of two surfactants, Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories), for the treatment of neonatal respiratory distress syndrome.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Bronchopulmonary Dysplasia

Interventions

DRUG

Exosurf

Infants received up to four intratracheal doses of the surfactant.

DRUG

Survanta

Infants received up to four intratracheal doses of the surfactant.

Sponsors & Collaborators

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Jeffrey D. Horbar, MD · University of Vermont

• Elizabeth C. Wright, PhD · George Washington University

• Avroy A. Fanaroff, MD · Case Western Reserve University

• Sheldon B. Korones, MD · University of Tennessee

• Seetha Shankaran, MD · Wayne State University

• Charles R. Bauer, MD · University of Miami

• Jon E. Tyson, MD MPH · University of Texas

• James A. Lemons, MD · Indiana University

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

• Barbara J. Stoll, MD · Emory University

• David K. Stevenson, MD · Stanford University

• LuAnn Papile, MD · University of New Mexico

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Max Age

6 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1991-01-31

Primary Completion

1992-01-31

Completion

1992-01-31

Countries

• United States

Study Locations