drugset / Trial / NCT00006401
Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
Phase 3
Completed
793 enrolled
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
To determine whether or not inhaled nitric oxide (iNO) safely decreases the incidence of chronic lung disease (CLD) in premature infants.
Timeline
- Start
- 2000-09
- Primary completion
- 2005-09
- Completion
- 2007-10
Publications
- Results Kinsella JP, Cutter GR, Walsh WF, Gerstmann DR, Bose CL, Hart C, Sekar KC, Auten RL, Bhutani VK, Gerdes JS, George TN, Southgate WM, Carriedo H, Couser RJ, Mammel MC, Hall DC, Pappagallo M, Sardesai S, Strain JD, Baier M, Abman SH. Early inhaled nitric oxide therapy in premature newborns with respiratory failure. N Engl J Med. 2006 Jul 27;355(4):354-64. doi: 10.1056/NEJMoa060442.
- Mourani PM, Kinsella JP, Clermont G, Kong L, Perkins AM, Weissfeld L, Cutter G, Linde-Zwirble WT, Abman SH, Angus DC, Watson RS; Prolonged Outcomes after Nitric Oxide (PrONOx) Investigators. Intensive care unit readmission during childhood after preterm birth with respiratory failure. J Pediatr. 2014 Apr;164(4):749-755.e3. doi: 10.1016/j.jpeds.2013.11.062. Epub 2013 Dec 31.
- Watson RS, Clermont G, Kinsella JP, Kong L, Arendt RE, Cutter G, Linde-Zwirble WT, Abman SH, Angus DC; Prolonged Outcomes After Nitric Oxide Investigators. Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year. Pediatrics. 2009 Nov;124(5):1333-43. doi: 10.1542/peds.2009-0114. Epub 2009 Oct 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nitric Oxide | Other / unclassified | 5 ppm | Inhaled |