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Acta Paediatr. 2019 Feb;108(2):275-281. doi: 10.1111/apa.14463. Epub 2018 Jul 5.

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

Author information

1
Department of Neonatology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
2
Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
3
Department of Neonatology, Hospices Civils de Lyon, Claude Bernard University, Lyon, France.
4
Department of Neonatology, La Paz University Hospital, Madrid, Spain.
5
INFANT Centre, University College Cork, Cork, Ireland.
6
NICU, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy.
7
Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
8
Department of Pediatrics, Research Unit for Neonatal Micro- and Macrocirculation, Medical University of Graz, Graz, Austria.

Abstract

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 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).

CONCLUSION:

Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age.

KEYWORDS:

Ages and stages questionnaire; Bayley scales of infant and toddler development; Cerebral near-infrared spectroscopy; Extremely preterm infants; Neurodevelopment

PMID:
29908039
DOI:
10.1111/apa.14463
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