Conditions: Lung Disease
Keywords: Preemie, Inhaled Nitric Oxide
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 800
Healthy volunteers: no

Brief 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).

Arms:
arm 1: INO administered by nasal continuous positive airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for between 7 and 21 days arm 2: Placebo gas administered by nasal continuous positive airway pressure, nasal cannula or face mask, for a maximum of 21 days.

Interventions: intervention 1: Nitric oxide intervention 2: Placebo
Intervention descriptions: intervention 1: Nitric Oxide vapour (gas) for inhalation (400 ppm) intervention 2: Placebo gas for inhalation

Protocol document: