Clinical Trial: Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Early Inhaled Nitric Oxide Therapy in Term and Near Term Infants With Respiratory Failure
Brief 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.
Detailed Summary:
Respiratory failure occurs in near term and term infants as a complication of perinatal aspiration syndromes, pneumonia, sepsis, respiratory distress syndrome and primary pulmonary hypertension. Recently a collaborative trial of the NICHD Neonatal Research Network and the Canadian Inhaled Nitric Oxide Study Group (the NINOS trial) demonstrated that inhaled nitric oxide (iNO) reduced the number of deaths and the need for extracorporeal membrane oxygenation (ECMO) therapy -- a lung bypass mechanism -- from 64 percent to 46 percent. The standard recommended threshold for initiation of iNO therapy, based on this trial, was an oxygenation index (OI) >=25.
The purpose of this study is to determine if administration of inhaled nitric oxide earlier in the course of respiratory failure and to infants with less severe respiratory failure, decreases the incidence of ECMO or death, as suggested by the sub-group analysis of the original NINOS trial. This prospective, randomized controlled trial tested whether initiating iNO therapy earlier would reduce death and reduce the use of ECMO therapy compared with the standard recommendation threshold.
Infants who were born at >34 weeks' gestation (near- or full-term) 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.
The study compared the outcome of infants received iNO at OI >15 and <25, with a control group that received a simulated early procedure with iNO actually given
Sponsor: NICHD Neonatal Research Network
Current Primary Outcome: Death or use of extracorporeal membrane oxygenation (ECMO) [ Time Frame: Hospital discharge or 120 days of life ]
Original Primary Outcome:
Current Secondary Outcome:
- Use of iNO therapy based on the standard recommended threshold [ Time Frame: Hospital Discharge or 120 days of life ]
- Progression to severe respiratory failure (OI>40) [ Time Frame: Hospital discharge or 120 days of life ]Severe respiratory failure, defined as OI >40
- Neurodevelopmental impairment [ Time Frame: 18-22 months corrected age ]
Original Secondary Outcome:
Information By: NICHD Neonatal Research Network
Dates:
Date Received: June 1, 2000
Date Started: August 1998
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015
