Trial intelligence / Profile preview

VON DRM Study

NCT00244101Phase 3

Key facts

Status: Completed
Start: Aug 2003
Primary completion: Jun 2009
Countries: 1
Sponsor: Vermont Oxford Network
Modality: Biologic

Drugs: bovactant
Conditions: respiratory distress syndrome (RDS)

Overview

Phase 3, randomised, open-label trial of bovactant in respiratory distress syndrome (RDS) (3 arms), sponsored by Vermont Oxford Network. Primary endpoint: Death or Chronic Lung Disease. Started Aug 2003; status: completed.

Design

3 arms

Study design: RandomizedOpen-label

PS Group
Intubation + Prophylactic Surfactant + Ventilation
NCPAP Group
Early NCPAP + Selective Surfactant
ISX Group
Intubation + Prophylactic Surfactant + Rapid Extubation to NCPAP

Who it enrols

Infants likely to be delivered at 26+0 to 29+6 weeks gestation with imminent delivery, no life-threatening anomalies, and no known lung maturity.

Endpoints

Primary

Death or Chronic Lung Disease36 weeks postmenstrual age

Secondary

Death36 weeks adjusted age
Chronic Lung Disease36 weeks adjusted age
Long-term outcomes2 years

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