Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
Status:
Terminated
Trial end date:
2003-08-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
NICHD Neonatal Research Network
Collaborators:
Canadian Institutes of Health Research (CIHR) Mallinckrodt National Center for Research Resources (NCRR)