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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

Lookup NU author(s): Dr Alan Fenton

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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 ( pound 1,697) 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. Copyright (c) 2007 S. Karger AG, Basel.


Publication metadata

Author(s): Field D, Elbourne D, Hardy P, Fenton AC, Ahluwalia J, Halliday HL, Subhedar N, Heinonen K, Aikio O, Grieve R, Truesdale A, Tomlin K, Normand C, Stocks J, INNOVO Trial Collaborating Grp

Publication type: Article

Publication status: Published

Journal: Neonatology

Year: 2007

Volume: 91

Issue: 2

Pages: 73-82

Print publication date: 01/01/2007

ISSN (print): 1661-7800

ISSN (electronic): 1661-7819

Publisher: S. Karger AG


Funding

Funder referenceFunder name
G106/1173Medical Research Council

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