title: Neonatal ventilation with inhaled nitric oxide vs. ventilatory support without inhaled nitric oxide for infants with severe respiratory failure born at or near term: the INNOVO multicentre randomised controlled trial.
abstract: BACKGROUND
  Evidence from European centres to support the use of nitric oxide (NO) in mature newborns with evidence of severe respiratory failure is sparse.
  
  
  METHODS
  Infants of >33 weeks' gestation, <28 days old, and with severe respiratory failure requiring ventilatory support were randomised to receive or not to receive inhaled NO (iNO). The study was not blinded.
  
  
  RESULTS
  Sixty infants were recruited (29 allocated iNO, 31 no iNO) from 15 neonatal units in the UK, Finland, Belgium and the Republic of Ireland. 15/60 recruited babies died, and 8.1% of the survivors (4/45) were classified as severely disabled at 1 year. There was no statistically significant difference between the randomised groups in terms of the primary outcome of death or severe disability by the corrected age of 1 year (relative risk = 0.96 (95% confidence interval = 0.46-2.03); p = 0.86) (Fisher's exact p = 1.00). The costs of NO were outweighed by reduced extra corporeal membrane oxygenation costs in the iNO group. The mean total hospitalisation costs were lower in the iNO group, although the mean difference (1,697 pounds) was not statistically significant (95% confidence interval = -14,472 to 11,478).
  
  
  CONCLUSIONS
  The results complement those of previous studies that suggest NO is cost-effective and reduces the need for extra corporeal membrane oxygenation in this group of babies. Overall survival rates compare unfavourably with results of US trials.
authors.affiliation: Department of Health Science, University of Leicester, London, UK. david.field@uhl-tr.nhs.uk
authors.forename: D
authors.initials: D
authors.lastname: Field
authors.forename: D
authors.initials: D
authors.lastname: Elbourne
authors.forename: P
authors.initials: P
authors.lastname: Hardy
authors.forename: A C
authors.initials: AC
authors.lastname: Fenton
authors.forename: J
authors.initials: J
authors.lastname: Ahluwalia
authors.forename: H L
authors.initials: HL
authors.lastname: Halliday
authors.forename: N
authors.initials: N
authors.lastname: Subhedar
authors.forename: K
authors.initials: K
authors.lastname: Heinonen
authors.forename: O
authors.initials: O
authors.lastname: Aikio
authors.forename: R
authors.initials: R
authors.lastname: Grieve
authors.forename: A
authors.initials: A
authors.lastname: Truesdale
authors.forename: K
authors.initials: K
authors.lastname: Tomlin
authors.forename: C
authors.initials: C
authors.lastname: Normand
authors.forename: J
authors.initials: J
authors.lastname: Stocks
mesh_terms: D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D005260:Female; D005865:Gestational Age; D006760:Hospitalization / Q000191:economics; D006801:Humans; D007231:Infant, Newborn; D015931:Intensive Care, Neonatal / Q000191:economics / Q000379:methods*; D008297:Male; D009569:Nitric Oxide / Q000627:therapeutic use*; D012121:Respiration, Artificial / Q000191:economics / Q000379:methods*; D012127:Respiratory Distress Syndrome, Newborn / Q000401:mortality / Q000628:therapy*; D015996:Survival Rate; D047929:Term Birth; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D009569:Nitric Oxide