Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

• Status: Terminated
• Trial end date: 1998-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Respiratory failure in term newborns is associated with increased rates of death and long-term neurodevelopmental problems. This large international multicenter trial randomized newborns who had failed to respond to intensive care, including high levels of ventilator support, to receive either inhaled nitric oxide (iNO) or 100 percent oxygen to test whether iNO would decrease their risk of dying or requiring temporary lung bypass. Infants were followed during their initial hospitalization; their outcome was assessed at 18 to 24 mos of age.

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

Details

• Lead Sponsor: NICHD Neonatal Research Network
• Collaborators: Medical Research Council of Canada; National Center for Research Resources (NCRR)
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

• Greater than 34 wks gestational age

• One or more of the following diagnoses: primary pulmonary hypertension of the newborn, respiratory distress syndrome, perinatal aspiration syndrome, pneumonia/sepsis, suspected pulmonary hypoplasia

• Oxygenation Index (OI) greater than 15 and less than 25 on 2 arterial blood gases at least 15 min apart

• Indwelling arterial line

• Echocardiography before randomization

• Parental consent

Exclusion Criteria:

• Congenital diaphragmatic hernia

• Known congenital heart disease

• Decision not to provide full therapy