Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Exosurf Neonatal vs Survanta in RDS
NCT01203358Phase 3
Key facts
- Status
- Completed
- Start
- Jan 1991
- Primary completion
- Jan 1992
- Countries
- 1
- Sponsor
- NICHD Neonatal Research Network
- Modality
- Polymer-based Nanoparticles, Recombinant Proteins and Enzymes, Small Molecules
- Conditions
- respiratory distress syndrome (RDS)
01
Overview
Phase 3, randomised trial in respiratory distress syndrome (RDS) comparing Surfactant 1 (Exosurf) with Surfactant 2 (Survanta) (2 arms). Primary endpoint: Death or bronchopulmonary dysplasia at 28 days. Started Jan 1991; status: completed.
02
Design
2 arms- Study design
- Randomized
Surfactant 1 (Exosurf)
Infants received up to four intratracheal doses of Exosurf Neonatal.
Surfactant 2 (Survanta)
Infants received up to four intratracheal doses of Survanta.
03
Who it enrols
Newborn infants weighing 501 to 1500 gm with respiratory distress syndrome receiving assisted ventilation with 30% oxygen or more.
04
Endpoints
Primary
Death or bronchopulmonary dysplasia
Secondary
Average fraction of inspired oxygen
Mean airway pressure
Beyond the preview
Go deeper on NCT01203358.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT01203358.