TY - JOUR T1 - Magnetic Resonance Biomarkers in Neonatal Encephalopathy (MARBLE): a prospective multicountry study JF - BMJ Open JO - BMJ Open DO - 10.1136/bmjopen-2015-008912 VL - 5 IS - 9 SP - e008912 AU - Peter J Lally AU - Shreela Pauliah AU - Paolo Montaldo AU - Badr Chaban AU - Vania Oliveira AU - Alan Bainbridge AU - Aung Soe AU - Santosh Pattnayak AU - Paul Clarke AU - Prakash Satodia AU - Sundeep Harigopal AU - Laurence J Abernethy AU - Mark A Turner AU - Angela Huertas-Ceballos AU - Seetha Shankaran AU - Sudhin Thayyil Y1 - 2015/09/01 UR - http://bmjopen.bmj.com/content/5/9/e008912.abstract N2 - Introduction Despite cooling, adverse outcomes are seen in up to half of the surviving infants after neonatal encephalopathy. A number of novel adjunct drug therapies with cooling have been shown to be highly neuroprotective in animal studies, and are currently awaiting clinical translation. Rigorous evaluation of these therapies in phase II trials using surrogate MR biomarkers may speed up their bench to bedside translation. A recent systematic review of single-centre studies has suggested that MR spectroscopy biomarkers offer the best promise; however, the prognostic accuracy of these biomarkers in cooled encephalopathic babies in a multicentre setting using different MR scan makers is not known.Methods and analysis The MR scanners (3 T; Philips, Siemens, GE) in all the participating sites will be harmonised using phantom experiments and healthy adult volunteers before the start of the study. We will then recruit 180 encephalopathic infants treated with whole body cooling from the participating centres. MRI and spectroscopy will be performed within 2 weeks of birth. Neurodevelopmental outcomes will be assessed at 18–24 months of age. Agreement between MR cerebral biomarkers and neurodevelopmental outcome will be reported. The sample size is calculated using the ‘rule of 10’, generally used to calculate the sample size requirements for developing prognostic models. Considering 9 parameters, we require 9×10 adverse events, which suggest that a total sample size of 180 is required.Ethics and dissemination Human Research Ethics Committee approvals have been received from Brent Research Ethics Committee (London), and from Imperial College London (Sponsor). We will submit the results of the study to relevant journals and offer national and international presentations.Trial registration number Clinical Trials.gov Number: NCT01309711. ER -