drugset / Trial / NCT00931632

Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants

NCT00931632

Phase 3 Completed 451 enrolled Mallinckrodt
RandomizedSingle-groupTriple-blindTreatment

Summary

This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.

Timeline

Start
2009-11
Primary completion
2013-05
Completion
2014-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 5 ppm Inhaled