title: 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.
authors.affiliation: Division of Neonatal Medicine, Mayo Clinic, Rochester, Minnesota; and ellsworth.marc@mayo.edu.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Ellsworth
authors.affiliation: Division of Neonatal Medicine, Mayo Clinic, Rochester, Minnesota; and.
authors.forename: Malinda N
authors.initials: MN
authors.lastname: Harris
authors.affiliation: Division of Neonatal Medicine, Mayo Clinic, Rochester, Minnesota; and.
authors.forename: William A
authors.initials: WA
authors.lastname: Carey
authors.affiliation: Center for Research, Education and Quality, Pediatrix Medical Group, Sunrise, Florida.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Spitzer
authors.affiliation: Center for Research, Education and Quality, Pediatrix Medical Group, Sunrise, Florida.
authors.forename: Reese H
authors.initials: RH
authors.lastname: Clark
mesh_terms: D000280:Administration, Inhalation; D004363:Drug Utilization / Q000639:trends*; D005260:Female; D005865:Gestational Age; D019983:Guideline Adherence; D006801:Humans; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D019102:Infant, Very Low Birth Weight; D007363:Intensive Care Units, Neonatal; D008297:Male; D009569:Nitric Oxide / Q000008:administration & dosage* / Q000009:adverse effects; D056687:Off-Label Use; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy*; D018570:Risk Assessment; D016896:Treatment Outcome; D014481:United States
chemical_list: D009569:Nitric Oxide
keywords: inhaled nitric oxide; neonate; prematurity; respiratory distress