A multicenter, randomized trial comparing synthetic surfactant with modified bovine surfactant extract in the treatment of neonatal respiratory distress syndrome. Vermont-Oxford Neonatal Network.

Abstract

OBJECTIVE:

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).

DESIGN:

Multicenter, randomized trial.

SETTING:

Thirty-eight neonatal intensive care units participating in the Vermont-Oxford Neonatal Network.

PATIENTS:

Premature infants (n = 1296) weighing 501 to 1500 g with RDS requiring assisted ventilation with 30% oxygen or more were enrolled within 6 hours of birth.

INTERVENTIONS:

Infants were randomly assigned to receive up to four intratracheal doses of the synthetic surfactant (Exosurf Neonatal, n = 644) or the modified bovine surfactant extract (Survanta, n = 652).

MAIN OUTCOME MEASURE:

The primary outcome measure was the occurrence of death or chronic lung disease 28 days after birth.

RESULTS:

Death or chronic lung disease occurred in 57% of the infants treated with Exosurf Neonatal and in 54% of those infants treated with Survanta (relative risk [RR], 0.95; 95% confidence interval [CI], 0.86 to 1.04). Infants with birth weights of 1001 to 1500 g who received Survanta had a significantly lower risk of chronic lung disease or death at 28 days (Survanta, 27% vs Exosurf, 34%; RR, 0.78; 95% CI, 0.60 to 0.99). Treatment with Survanta led to significant improvement in several secondary outcome measures. Survanta-treated infants received less supplemental oxygen and had lower mean airway pressure 6 and 72 hours after treatment. Survanta-treated infants had significantly fewer pneumothoraces (Survanta, 9% vs Exosurf, 15%; RR, 0.60; 95% CI, 0.44 to 0.81). There were no differences between the groups in the incidence of other neonatal complications.

CONCLUSION:

Although no differences were noted between Survanta- and Exosurf-treated infants regarding the primary outcome of death or chronic lung disease at 28 days of age, the significant improvement in secondary clinical outcomes suggests that Survanta is more effective than Exosurf Neonatal in the treatment of established RDS.

• Journal: Pediatrics (Pediatrics) Vol. 97 Issue 1 Pg. 1-6 (Jan 1996) ISSN: 0031-4005 [Print] United States
• PMID: 8545199 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Comment)

Chemical References

• Biological Products
• Drug Combinations
• Fatty Alcohols
• Pulmonary Surfactants
• Phosphorylcholine
• Polyethylene Glycols
• dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination
• beractant

Topics

• Biological Products
• Chronic Disease
• Drug Combinations
• Fatty Alcohols (therapeutic use)
• Female
• Humans
• Infant, Low Birth Weight
• Infant, Newborn
• Infant, Premature
• Lung Diseases (etiology)
• Male
• Oxygen Inhalation Therapy
• Phosphorylcholine
• Polyethylene Glycols (therapeutic use)
• Pulmonary Surfactants (therapeutic use)
• Respiratory Distress Syndrome, Newborn (complications, drug therapy, mortality)
• Risk