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

Bronchopulmonary Dysplasia Clinical Trial

Official title:
The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01748045
Study type Interventional
Source Tufts Medical Center
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date March 2013
Completion date July 2014
View Details
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