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Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial
ML. Hansen, A. Pellicer, C. Gluud, E. Dempsey, J. Mintzer, S. Hyttel-Sørensen, AM. Heuchan, C. Hagmann, E. Ergenekon, G. Dimitriou, G. Pichler, G. Naulaers, G. Cheng, H. Guimarães, J. Tkaczyk, KB. Kreutzer, M. Fumagalli, O. Claris, P. Lemmers, S....
Language English Country Great Britain
Document type Clinical Trial Protocol, Clinical Trial, Phase III, Journal Article, Pragmatic Clinical Trial, Randomized Controlled Trial
Grant support
18-3-0133
Elsass Fonden
N/A
Svend Andersen Fonden
NLK
BioMedCentral
from 2000-04-01
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Directory of Open Access Journals
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ROAD: Directory of Open Access Scholarly Resources
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- MeSH
- Spectroscopy, Near-Infrared methods MeSH
- Gestational Age MeSH
- Humans MeSH
- Monitoring, Physiologic methods MeSH
- Hypoxia, Brain diagnostic imaging prevention & control MeSH
- Infant, Extremely Premature * MeSH
- Infant, Newborn MeSH
- Oximetry methods MeSH
- Cerebrum diagnostic imaging MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Infant, Newborn MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Pragmatic Clinical Trial MeSH
- Clinical Trial Protocol MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants. METHODS/DESIGN: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants. DISCUSSION: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.
Copenhagen Trial Unit Rigshospitalet Blegdamsvej 9 2100 Copenhagen Denmark
Department of Intensive Care Rigshospitalet Blegdamsvej 9 2100 Copenhagen Denmark
Department of Neonatology Hospices Civil De Lyon 3 Quai des Célestins 69002 Lyon France
Department of Neonatology La Paz University Hospital Paseo De La Castellana 261 28046 Madrid Spain
Department of Neonatology Oslo University Hospital Kirkeveien 166 0450 Oslo Norway
Department of Neonatology Poznan University of Medical Sciences Polna 33 60 535 Poznań Poland
Department of Neonatology Rigshospitalet Blegdamsvej 9 2100 Copenhagen Denmark
Department of Neonatology Royal Hospital for Children 1345 Govan Rd Glasgow G51 4TF UK
Department of Neonatology University Hospital Leuven Herestraat 49 Leuven Belgium
Department of Neonatology University Hospital Motol 5 Uvalu 84 150 06 Prague 5 Czech Republic
Department of Neonatology Wilhelmina Children's Hospital Lundlaan 6 3584 EA Utrecht Netherlands
Department of Pediatrics Medical University of Graz Auenbruggerplatz 30 Graz Austria
NICU Department of Pediatrics University General Hospital of Patras 265 04 Patras Greece
References provided by Crossref.org
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