Original ArticleMulticenter Randomized Controlled Trial of Inhaled Nitric Oxide for Pediatric Acute Respiratory Distress Syndrome
Section snippets
Methods
The study protocol was approved by the institutional review board at each participating center. Patient enrollment took place from 2003 through 2005. Because of slow enrollment, the study was terminated prematurely, and because of the acquisition of INO Therapeutics by Ikaria and a shift in clinical focus, the data were not analyzed until currently.
All patients meeting study criteria were eligible for the study and were approached for consent. Inclusion criteria consisted of the following:
Results
A total of 55 patients were enrolled in the study (Figure; available at www.jpeds.com); 29 patients received placebo and 26 iNO. Two patients randomized to iNO were withdrawn from the study as the result of premature termination of study gas. One patient that was randomized to receive placebo inadvertently received iNO and was evaluated as a part of the iNO cohort. There was no difference in age at time of enrollment (P = .14) and there is an equal distribution of primary diagnosis between
Discussion
We report the results of a prospective randomized blinded trial on the impact of iNO on outcomes in pediatric ARDS. We found that iNO led to a significant reduction in the duration of mechanical ventilation and to a significantly greater rate of ECMO-free survival. Previous studies of iNO in pediatric ARDS were either designed with or allowed for a crossover to iNO, precluding an analysis on the impact of iNO on outcomes in pediatric ARDS.10, 11
Studies in adult ARDS have not demonstrated
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Supported by the Ikaria Corporation (formerly INO Therapeutics). The authors declare no conflicts of interest.