PEDIATRICS Vol. 124 No. 5 November 2009, pp. 1333-1343 (doi:10.1542/peds.2009-0114)
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ARTICLE |
Clinical and Economic Effects of iNO in Premature Newborns With Respiratory Failure at 1 Year
a Clinical Research, Investigation, and Systems Modeling of Acute Illness Laboratory, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
b Pediatric Heart Lung Center, University of Colorado School of Medicine/Children's Hospital, Denver, Colorado
c Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania
d Department of Pediatrics, Ohio State University School of Medicine, Columbus, Ohio
e Research Institute of Nationwide Children's Hospital, Columbus, Ohio
f Department of Biostatistics, University of Alabama, Birmingham, Alabama
g ZD Associates, Perkasie, Pennsylvania
BACKGROUND: The 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.
METHODS: Premature newborns (gestational age 
34 w, birth weight 500–1250 g) with respiratory failure randomly received 5 ppm iNO or placebo within 48 h of birth until 21 d or extubation. We assessed clinical outcomes via in-person neurodevelopmental evaluation at 1 y corrected age and telephone interviews every 3 m. We estimated costs from detailed hospital bills and interviews, converting all costs to 2008 US$. Of 793 trial subjects, 631 (79.6%) contributed economic data, and 455 (77.1% of survivors) underwent neurodevelopmental evaluation.
RESULTS: At 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.
CONCLUSIONS: Subjects 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.
Key Words: prematurity • inhaled nitric oxide • long-term effects • quality-adjusted survival • health care costs • randomized • controlled trial • respiratory distress syndrome • chronic lung disease • bronchopulmonary dysplasia • intraventricular hemorrhage
Abbreviations: iNO—inhaled nitric oxide • RCT—randomized, controlled trial • CLD—chronic lung disease • CUS—cranial ultrasound • ICH—intracranial hemorrhage • MV—mechanical ventilation • NDI—neurodevelopmental impairment • MDI—Mental Developmental Index • PDI—Psychomotor Developmental Index • HRQoL—health-related quality of life • OI—oxygenation index • IQR—interquartile range • ED—emergency department • QALY—quality-adjusted life-year • ICER—incremental cost-effectiveness ratio • LOS—length of stay
Accepted Jun 18, 2009.
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