NCT01748045

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

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

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Tufts Medical Center · Academic / Other
• Sex: All
• Age: 30 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DRUG	inhaled nitric oxide
DRUG	Placebo Comparator - nitrogen gas

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-12-12
• Last updated: 2017-07-19
• Results posted: 2017-07-19

Locations

1 site across 1 country: United States