Off-Label Use of Inhaled Nitric Oxide After Release of NIH Consensus Statement

Abstract

BACKGROUND: Inhaled nitric oxide (iNO) therapy is an off-label medication in infants <34 weeks’ gestational age. In 2011, the National Institutes of Health released a statement discouraging routine iNO use in premature infants. The objective of this study was to describe utilization patterns of iNO in American NICUs in the years surrounding the release of the National Institutes of Health statement. We hypothesized that iNO prescription rates in premature infants have remained unchanged since 2011. METHODS: The Pediatrix Medical Group Clinical Data Warehouse was queried for the years 2009–2013 to describe first exposure iNO use among all admitted neonates stratified by gestational age. RESULTS: Between 2009 and 2013, the rate of iNO utilization in 23- to 29-week neonates increased from 5.03% to 6.19%, a relative increase of 23% (confidence interval: 8%–40%; P = .003). Of all neonates who received iNO therapy in 2013, nearly half were <34 weeks’ gestation, with these infants accounting for more than half of all first exposure iNO days each year of the study period. CONCLUSIONS: The rates of off-label iNO use in preterm infants continue to rise despite evidence revealing no clear benefit in this population. This pattern of iNO prescription is not benign and comes with economic consequences.