NCT01503801

Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 1 Hour – 30 Days
• Healthy volunteers: Not accepted

Summary

Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: 1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death 2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

Detailed description

Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia. Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control. During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Nitric Oxide	The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off
DEVICE	respiratory support	Routine respiratory support.

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2012-01-04
• Last updated: 2013-01-28

Locations

1 site across 1 country: China