NCT00016523

Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 120 Hours
• Healthy volunteers: Not accepted

Summary

This multicenter trial tested whether inhaled nitric oxide would reduce death or the need for oxygen in preterm infants (less than 34 weeks gestational age) with severe lung disease.

Detailed description

This multicenter, randomized, double-masked, controlled clinical trial evaluated the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with respiratory failure secondary to respiratory distress syndrome (RDS), sepsis/pneumonia, aspiration syndrome, idiopathic pulmonary hypertension and/or suspected pulmonary hypoplasia. Infants were followed until death or discharge to home. The trial compared iNO therapy to mock gas delivery as the control, and otherwise incorporated conventional management strategies (including treatment with surfactant and high frequency ventilation as adjuncts to iNO therapy). During the initial dosing, iNO was started at 5 ppm and could be increased to 10 ppm. If the infant did not respond, study gas was discontinued. For infants who responded to study gas, a gradual weaning was initiated. The total exposure to study gas did not exceed 336 hours (14 days). Infants were monitored for signs of toxicity. Medical and neurodevelopmental outcome of surviving infants were assessed at 18 to 22 months corrected age by masked, certified examiners.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Respiratory Distress Syndrome (RDS)
• Sepsis
• Pneumonia
• Hypertension, Pulmonary

Interventions

Type	Name	Description
DRUG	Inhaled nitric oxide	Started at 5 ppm and could be increased to 10 ppm
DRUG	Placebo	Started at 5 ppm and could be increased to 10 ppm

Timeline

• Start date: 2001-01-01
• Primary completion: 2003-09-01
• Completion: 2006-05-01
• First posted: 2001-05-16
• Last updated: 2017-09-26

Locations

17 sites across 1 country: United States