At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 617 enrolled
Drug / intervention
Exosurf +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome
In Brief
A Phase 3 clinical trial evaluating Exosurf and Survanta for Infant, Newborn and 4 related conditions. Completed, enrolled 617 participants across 13 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Bronchopulmonary Dysplasia
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
1991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 1991
Primary CompletionJan 1992
First PostedSep 2010
TodayJul 2026
First PostedSep 16, 2010
Enrollment StartJan 1, 1991
Primary CompletionJan 1, 1992
TodayJul 1, 2026
Enrollment to primary: 1 yearPosted 15.8 years ago
Interventions
Exosurfdrug
Infants received up to four intratracheal doses of the surfactant.
Survantadrug
Infants received up to four intratracheal doses of the surfactant.