On April 29, 1996, the Data Saftey and Monitoring Committee recommended that enrollment be closed based on an interim analysis of 207 randomized patients which indicated that the primary outcome, 20% reduction in death or ECMO among patients receiving nitric oxide, had been met without evidence of toxicity. The congenital diaphragmatic hernia pilot showed no apparent benefit from nitric oxide. Follow-up evaluation at 18 months of age is underway and progressing smoothly. The protocol has been modified to open label inhaled nitric oxide under the NICHD revised INO protocol IND. Baseline, safety and outcome data have been collected on these patients.
NIH ExPorter
NIH ExPorter