Early Inhaled Nitric Oxide for Respiratory Failure in Newborns

• Status: Terminated
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of extracorporeal membrane oxygenation (ECMO) -- temporary lung bypass -- therapy compared with the standard recommendation threshold. Infants who were born at >34 weeks' gestation were enrolled when they required assisted ventilation and had an oxygenation index (OI) >15 and <25 on any 2 measurements in a 12-hour interval. Infants were randomized to receive either early iNO or to simulated initiation of iNO (control). Infants who had an increase in OI to 25 or more were given iNO as standard therapy. The neurodevelopment of the subjects were evaluated at 18-22 months corrected age.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Canadian Institutes of Health Research (CIHR); Mallinckrodt; National Center for Research Resources (NCRR)
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Infants born at >34 weeks gestational age

• Require assisted ventilation for hypoxic respiratory failure

• Have a diagnosis of primary persistent pulmonary hypertension (PPHN), respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, or suspected pulmonary hypoplasia

• Have an oxygenation index >15 and <25 based on 2 arterial blood gases taken at least 15 minutes apart or an Fi02 >80%

• In-dwelling arterial line

• Parental consent

Exclusion Criteria:

• Known structural congenital heart disease, except patent ductus arteriosus and atrial level shunts

• Congenital diaphragmatic hernia

• Use of high frequency jet ventilation at the time of randomization

• Prior exposure to inhaled nitric oxide therapy