A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial
Authors
Hyttel-Sorensen, Simon
van, Bel Frank
Benders, Manon
Claris, Olivier
Dempsey, Eugene
Fumagalli, Monica
Greisen, Gorm
Grevstad, Berit
Hagmann, Cornelia
Hellström-Westas, Lena
Lemmers, Petra
Lindschou, Jane
Naulaers, Gunnar
van, Oeveren Wim
Pellicer, Adelina
Pichler, Gerhard
Roll, Claudia
Skoog, Maria
Winkel, Per
Wolf, Martin
Gluud, Christian
Publication Date
2013-05-01ISSN
1745-6215
Language
English
Type
Article
Metadata
Show full item recordCitation
Hyttel-Sorensen, S., Austin, T., van, B. F., Benders, M., Claris, O., Dempsey, E., Fumagalli, M., et al. (2013). A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial. https://doi.org/10.1186/1468-6708-14-120
Abstract
Abstract Background Every year in Europe about 25,000 infants are born extremely preterm. These infants have a 20% mortality rate, and 25% of survivors have severe long-term cerebral impairment. Preventative measures are key to reduce mortality and morbidity in an extremely preterm population. The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy (NIRS) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2. Methods/Design SafeBoosC is a randomized, blinded, multinational, phase II clinical trial. The inclusion criteria are: neonates born more than 12 weeks preterm; decision to conduct full life support; parental informed consent; and possibility to place the cerebral NIRS oximeter within 3 hours after birth. The infants will be randomized into one of two groups. Both groups will have a cerebral oximeter monitoring device placed within three hours of birth. In the experimental group, the cerebral oxygenation reading will supplement the standard treatment using a predefined treatment guideline. In the control group, the cerebral oxygenation reading will not be visible and the infant will be treated according to the local standards. The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55% to 85%, that is, the ‘burden of hypoxia and hyperoxia’ expressed in ‘%hours’. To detect a 50% difference between the experimental and control group in %hours, 166 infants in total must be randomized. Secondary outcomes are mortality at term date, cerebral ultrasound score, and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age, magnetic resonance imaging at term, blood biomarkers at 6 and 64 hours after birth, and adverse events. Discussion Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants. It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia. Trial registration ClinicalTrial.gov, NCT01590316
Identifiers
External DOI: https://doi.org/10.1186/1468-6708-14-120
This record's URL: http://www.dspace.cam.ac.uk/handle/1810/244583
Rights
Rights Holder: Simon Hyttel-Sorensen et al.; licensee BioMed Central Ltd.
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