On April 29, 1996, the Data Safety 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 will be complete in early 1998. The protocol has been modified to open label inhaled nitric oxide under the NICHD revised protocol IND. Baseline, safety, outcome and 18 month follow-up data is collected on these patients.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
36
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Stanford University
Department
Type
DUNS #
800771545
City
Stanford
State
CA
Country
United States
Zip Code
94305
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