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

Trials

Christian Gluud⁶  Martin Wolf^1,12  Per Winkel⁶  Maria Skoog⁶  Claudia Roll⁴  Gerhard Pichler¹  Adelina Pellicer⁸  Wim van Oeveren^1,10  Gunnar Naulaers⁵  Jane Lindschou⁶  Petra Lemmers³  Lena Hellström-Westas²  Cornelia Hagmann⁹  Berit Grevstad⁶  Gorm Greisen⁷  Monica Fumagalli^1,14  Eugene Dempsey^1,13  Olivier Claris^1,11  Manon Benders³  Frank van Bel³  Topun Austin^1,15  Simon Hyttel-Sorensen⁷ 

[1] Department of Pediatrics, Medical University of Graz, Auenbruggerplatz 30, Graz, Austria;Department of Women’s and Children’s Health Uppsala Universitet, University Hospital, Uppsala, 751 85, Sweden;Wilhelmina Children’s Hospital, Universitair Medisch Centrum Utrecht, KE 04.123.1, PO Box 85090, Utrecht, 3508 AB, The Netherlands;Department of Neonatology and Paediatric Intensive Care, Vest Children’s Hospital Datteln, University Witten-Herdecke, Dr.-Friedrich-Steiner-Str. 5, Datteln, 45711, Germany;Katholieke Universiteit Leuven, Herestraat 49, Leuven, 3000, Belgium;Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Blegdamsvej 9, Copenhagen, DK-2100, Denmark;Department of Neonatology, Rigshospitalet, Blegdamsvej 9, Copenhagen, DK-2100, Denmark;Department of Neonatology, La Paz University Hospital, Paseo de la Castellana 261, Madrid, 28046, Spain;Division of Neonatology, University of Zurich, Zurich, 8091, Switzerland;Haemoscan B.V, Stavangerweg 23, Groningen, JC, 9723, The Netherlands;Department of Neonatology, Hopital Femme Mere Enfants, 59, Boulevard Pinel, Bron, 69500, France;Biomedical Optics Research Laboratory, Division of Neonatology, University Hospital Zurich, Frauenklinikstr 10, Zurich, 8091, Switzerland;Department of Paediatrics and Child Health, University College Cork, College Road, Cork, Ireland;NICU, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Milan, Via della Commenda 12, Milan, IT- 20122, Italy;Rosie Maternity Hospital Cambridge University Hospitals NHS Foundation Trust Hills Road, Cambridge, CB2 0SW, UK

关键词: Protocol;    Near infrared spectroscopy;    Preterm;    Randomized clinical trial;   

Others  :  1094151
DOI  :  10.1186/1745-6215-14-120

 received in 2013-02-11, accepted in 2013-04-15,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Hyttel-Sorensen et al.; licensee BioMed Central Ltd.

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