NCT01203358

Exosurf Neonatal and Survanta for Treatment of Respiratory Distress Syndrome

Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 6 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

The NICHD Neonatal Research Network conducted a randomized trial at 11 centers comparing the efficacy of two surfactants -- Exosurf Neonatal (Burroughs Wellcome Co.) and Survanta (Ross Laboratories) -- for the treatment of neonatal respiratory distress syndrome. Newborn infants with birth weights of 501-1500g with respiratory distress syndrome who were receiving assisted ventilation with 30% oxygen or more within 6 hours of birth were enrolled between January 1991 and January 1992. Infants were randomly assigned to receive up to four intratracheal doses of either Exosurf Neonatal or Survanta.

Conditions

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

Interventions

Type	Name	Description
DRUG	Exosurf	Infants received up to four intratracheal doses of the surfactant.
DRUG	Survanta	Infants received up to four intratracheal doses of the surfactant.

Timeline

• Start date: 1991-01-01
• Primary completion: 1992-01-01
• Completion: 1992-01-01
• First posted: 2010-09-16
• Last updated: 2019-03-22

Locations

13 sites across 1 country: United States