Study: Inhaled Nitric Oxide Use in Pediatric Intensive Care (iNO)
Study Type: Prospective Observational Cohort Study
Study Period: October 2015 – September 2016
Enrollment: 576
Consent: No
Purpose:
Acute lung injury (ALI) occurs in approximately 9% of mechanically ventilated children with 80% progressing to ALI’s most severe form, acute respiratory distress syndrome (ARDS). Inhaled nitric oxide (iNO) is an important therapy for neonates with persistent pulmonary hypertension of the newborn, older children with pulmonary hypertension and patients with congenital heart disease. It has been hypothesized that iNO should benefit patients with ALI/ARDS by improving oxygenation and limiting ventilator and oxygen induced lung injury. Clinical trials, however, have not been able to prove this hypothesis.
Despite lack of proof of efficacy, iNO continues to be frequently used in pediatric ALI/ARDS. The continued use of iNO may be based on bias towards intervention and the perceived lack of toxic effects of iNO. Inhaled nitric oxide is variably used among the sites within the CPCCRN. In the recently published TOPICC study, 285 (2.8%) of the 10,078 enrolled subjects received iNO during the PICU admission, which represents approximately 500 patients per year.
iNO was a prospective observational cohort study, and its descriptive results will be used to inform the design and implementation of a randomized, controlled trial of iNO in pediatric intensive care (medical and cardiac).
Study Documents:
Study Datasets:
- To obtain the Public Release Research Dataset follow the procedures outlined on the NICHD Data and Specimen Hub (DASH) website.