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

Lung Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00551642
Study type Interventional
Source Mallinckrodt
Contact
Status Completed
Phase Phase 3
Start date May 29, 2005
Completion date July 17, 2015
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