drugset / Trial / NCT01748045

Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants

NCT01748045

Phase 2/3 Terminated 3 enrolled Tufts Medical Center Mallinckrodt · collab
RandomizedParallel-groupTriple-blindPrevention

Summary

The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.

Timeline

Start
2013-03
Primary completion
2014-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Nitric Oxide Other / unclassified 2 ppm Inhaled