Novel biomarkers in cooled newborns (Oct 2013)
Research type
Research Study
Full title
A study of novel biomarkers and severity of brain injury in newborns undergoing therapeutic hypothermia
IRAS ID
114529
Contact name
Divyen K Shah
Contact email
Sponsor organisation
Barts Health NHS Trust
Research summary
Perinatal hypoxia-ischaemia (HI) is an important condition which occurs when a baby has been deprived of blood or oxygen supply either before or during birth. It is an important cause of death and disability in survivors. Treatments such as cooling result in an overall reduction in death and disability following HI. However we are unable to predict which babies are most likely to benefit from this treatment. In our study we will investigate an extensive panel of blood and urine biomarkers which reflect processes such as inflammation, and neuronal and non-neuronal cell damage in the central nervous system, triggered by HI. The biomarkers will be correlated with clinical outcomes. This will refine and improve clinical practice, and will help us characterize in more detail the profile of each baby, so that we have a more objective assessment of which babies within the HI group would benefit most from interventions such as cooling. Over a two year period, 100 babies born with HI from the Royal London Hospital, the Homerton Hospital, Norfolk and Norwich Hospital, and other centres will have blood and urine samples taken on day 1, 3 (cooling) and again between days 5 and 7 (post rewarming). The results of these analyses will be be compared to routine clinical outcomes including the neurological examination at the time of discharge, the EEG monitoring babies routinely receive, findings on brain MRI and the progress of the babies at follow-up, after discharge. Our aim is to develop a comprehensive panel of biomarkers which will show with increased reliability which babies would benefit most from brain protective treatment after HI. Such a tool could be used to assess the efficacy of new brain protective treatments, which could be administered very early in order to reverse the effect of HI in the immature brain.
REC name
London - Bromley Research Ethics Committee
REC reference
13/LO/1738
Date of REC Opinion
17 Dec 2013
REC opinion
Further Information Favourable Opinion