-
Randomized Controlled Trial Multicenter Study
Clinical and economic effects of iNO in premature newborns with respiratory failure at 1 year.
- R Scott Watson, Gilles Clermont, John P Kinsella, Lan Kong, Robert E Arendt, Gary Cutter, Walter T Linde-Zwirble, Steven H Abman, Derek C Angus, and Prolonged Outcomes After Nitric Oxide Investigators.
- Department of Critical Care Medicine, Clinical Research, Investigation, and Systems Modeling of Acute Illness Laboratory, University of Pittsburgh, Pittsburgh, Pennsylvania 15261, USA.
- Pediatrics. 2009 Nov 1; 124 (5): 1333-43.
BackgroundThe long-term consequences of inhaled nitric oxide (iNO) use in premature newborns with respiratory failure are unknown. We therefore studied the clinical and economic outcomes to 1 year of corrected age after a randomized controlled trial of prophylactic iNO.MethodsPremature newborns (gestational age
ResultsAt 1 y corrected age, survival was not different by treatment arm (79.2% iNO vs. 74.5% placebo, P = .12), nor were other post-discharge outcomes. For subjects weighing 750-999 g, those receiving iNO had greater survival free from neurodevelopmental impairment (67.9% vs. 55.6%, P = .04). However, in subjects weighing 500-749 g, iNO led to greater oxygen dependency (11.7% vs. 4.0%, P = .04). Median total costs were similar ($235,800 iNO vs. $198,300 placebo, P = .19). Quality-adjusted survival was marginally better with iNO (by 0.011 quality-adjusted life-years/subject). The incremental cost-effectiveness ratio was $2.25 million/quality-adjusted life-year.ConclusionsSubjects in both arms commonly experienced neurodevelopmental and pulmonary morbidity, consuming substantial health care resources. Prophylactic iNO beginning in the first days of life did not lower costs and had a poor cost-effectiveness profile. Notes
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