Safeguarding the brain of our smallest children
– a phase II feasibility randomised clinical trial on near-infrared spectroscopy monitoring combined with a treatment guideline in premature infants: http://www.clinicaltrials.gov/ct2/results?term=NCT01590316
Stabilising cerebral oxyginationSafeBoosC will enroll 166 preterm infants from 12 European countries. Our primary objective is to examine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants in the first 72 hours of life through the application of NIRS and the implementation of a clinical treatment guideline. Reducing brain injuryWe hypothesise that cerebral monitoring readings outside the target range with NIRS coupled with a treatment guideline on responses to out of range values would reduce the burden of hypo- and hyperoxia, consequently reducing brain injury. A randomised clinical trialThe trial will only randomise participants after receiving approval from the national competent authorities and regional ethics committees as well as parental informed consent. The trial will be conducted in compliance with good clinical practices and external monitoring.
Dedicated oximeterSafeBoosC will also develop and test a prototype cerebral oximeter dedicated for use in small, extremely preterm infants.
FundingSafeBoosC was funded in Jan 2012 by The Danish Council for Strategic Research with 11.1 mio dkk. The project was presented in national TV (in Danish) http://nyhederne.tv2.dk/article.php/id-45747015:flere-babyer-kan-undg%C3%A5-hjerneskade.html