This multinational, multicenter, randomized, double-masked controlled clinical trial has been designed to evaluate the efficacy of inhaled nitric oxide (INO) in the treatment of term and near-term infants with hypoxic respiratory failure. The proposed trial will compare INO therapy to a control group that receives either oxygen or no flow as a control. Infants greater than or equal to 34 weeks gestation with the diagnoses of respiratory distress syndrome, meconium aspiration, sepsis/pneumonia, idiopathic persistent pulmonary hypertension of the newborn, suspected pulmonary hypoplasia, and congenital diaphragmatic hernia will be eligible for the trial. The primary outcome will examine INO's ability to reduce the need for extracorporeal membrane oxygenation (ECMO) or death. The trial is being conducted jointly by the Canadian Inhaled Nitric Oxide Study Group (CINOS) and the NICHD Neonatal Intensive Care Units Network. Infants are followed to death or discharge to home with a neuro- evelopmental assessment obtained at 18 - 24 months corrected age on the surviving infants.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000750-27S1
Application #
6290959
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
27
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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