Comparison Surfactant Trial

Study Purpose

The purpose of the Surfactant Trial was to compare the efficacy of a synthetic surfactant (Exosurf Neonatal, Burroughs-Wellcome Co) and a modified bovine surfactant extract (Survanta, Ross Laboratories) in the treatment of neonatal respiratory distress syndrome (RDS).

Study Design

Multicenter randomized controlled clinical trial in 38 Neonatal Intensive Care Units in Vermont Oxford Network.

Study Synopsis

The Surfactant Trial enrolled and randomized 1,296 very low birth weight infants of 501-1500 grams with RDS to receive up to four intratracheal doses of either synthetic surfactant (Exosurf Neonatal) or modified bovine surfactant (Survanta). There was no overall difference in death or chronic lung disease between the study groups. Infants 1001 to 1500 grams who received Survanta had a significantly lower risk of chronic lung disease or death at 28 days. Infants treated with Survanta had significant improvement in secondary outcome measures: less supplemental oxygen and lower mean airway pressure at 6 and 72 hours; and fewer pneumothoraces.

Status

Completed and Published.

Citation

Vermont-Oxford Neonatal Network.(1996).A Multicenter, Randomized Trial Comparing Synthetic Surfactant With Modified Bovine Surfactant Extract in the Treatment of Neonatal Respiratory Distress Syndrome. Vermont -Oxford Neonatal Network. Pediatrics, 97(1), 1-6.

Study Sponsors

Our thanks to our sponsors: McDonald's Award for Excellence

Primary Investigators
Roger F. Soll, MD, University of Vermont College of Medicine

Trial Coordinator
Kathy Leahy, RN, NNP, University of Vermont.

Steering Committee
Jeffrey D. Horbar, MD, University of Vermont College of Medicine
Jerold F. Lucey, MD, University of Vermont College of Medicine
M. Maurer, MD, St. John's Mercy Medical Center
D. Levine, MD, Good Samaritan Hospital
M. Stern, MD, Plantation General Hospital