Inhaled Nitric Oxide Study for Respiratory Failure in Newborns

Trial ID or NCT#



not recruiting iconNOT RECRUITING


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.

Official Title

The Randomized Inhaled Nitric Oxide Study (NINOS) in Full-Term and Nearly Full-Term Infants With Hypoxic Respiratory Failure

Eligibility Criteria

Ages Eligible for Study: Younger than 14 Days
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - Congenital diaphragmatic hernia - Known congenital heart disease - Decision not to provide full therapy


David K. Stevenson, M.D.