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No neurodevelopmental benefit of cerebral oximetry in the first randomised trial in preterm infants during the first days of life (SafeBoosC II)

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AIM: Cerebral hypoxia has been associated with neurodevelopmental impairment. We studied whether reducing cerebral hypoxia in extremely preterm infants during the first 72 hours of life affected neurological outcomes at two years of corrected age.

METHODS: In 2012-2013 the phase II randomised Safeguarding the Brains of our Smallest Children trial compared visible cerebral near infrared spectroscopy (NIRS) monitoring in an intervention group and blinded NIRS monitoring in a control group. Cerebral hypoxia was significantly reduced in the intervention group. We followed up 115 survivors from eight European centres at two years of corrected age, by conducting a medical examination and assessing their neurodevelopment with the Bayley Scales of Infant and Toddler Development, Second or Third Edition and the parental Ages and Stages Questionnaire, (ASQ).

RESULTS: There were no respective differences between the intervention (n=65) and control (n=50) groups with regard to the mean mental developmental index (89.6 ±19.5 versus 88.4 ±14.7, p=0.77), ASQ score (215 ±58 versus 213 ±58, p=0.88) and the number of children with moderate-to-severe neurodevelopmental impairment (10 versus six, p=0.58).

CONCLUSIONS: Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age. This article is protected by copyright. All rights reserved.

OriginalsprogEngelsk
TidsskriftActa paediatrica
Vol/bind108
Udgave nummer2
Sider (fra-til)275-281
ISSN1651-2227
DOI
StatusUdgivet - 2019

ID: 54639653