NCT00551642

Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 26 Hours
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.

Detailed description

Although the effects of inhaled Nitric Oxide on pulmonary vascular tone are well-described and relevant to term infants with persistent pulmonary hypertension, the pathophysiology of respiratory failure in preterm infants may be quite different. Chronic lung disease (CLD) represents the final pathway of a heterogeneous group of pulmonary disorders of infancy that usually start in the neonatal period. CLD most commonly occurs in preterm (\<30 weeks of gestational age (GA) infants with birth weights less than 1,500 grams (g), and especially in those very preterm (\<26 weeks GA) with birth weights less than 1,000 g, and who have been treated for respiratory distress syndrome (RDS).

Conditions

• Lung Disease

Interventions

Type	Name	Description
DRUG	Nitric oxide	Nitric Oxide vapour (gas) for inhalation (400 ppm)
DRUG	Placebo	Placebo gas for inhalation

Timeline

• Start date: 2005-05-29
• Primary completion: 2008-03-16
• Completion: 2015-07-17
• First posted: 2007-10-31
• Last updated: 2021-02-05
• Results posted: 2010-10-18

Locations

35 sites across 9 countries: Belgium, Finland, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom