MARINAC Study
Research type
Research Study
Full title
Magnetic Resonance in Infection Primed Neonatal Encephalopathy and N-acetyl cysteine
IRAS ID
184200
Contact name
Sudhin Thayyil
Contact email
Sponsor organisation
Joint Research Compliance Office
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Babies who are born after a period of low blood flow and oxygen to the fetal brain (neonatal encephalopathy) and at high risk of permanent brain injury and long term neurodisability including cerebral palsy. Although cooling therapy reduces this injury to an extent, it does not work in all babies, particularly when there is a co-existent infection along with the ischemic brain injury (dual hit brain injury). Accurate MRI methods of quantifying the brain injury and prognosticating long term outcome will speed up the drug development for increasing the neuro protective efficacy of cooling therapy. As a part of a large NIHR funded study we have developed such MRI techniques, but these take unfeasibly long (30 minutes) to perform outside of a research environment. Our collaborators in South Carolina have also shown that, N-acetyl cysteine (NAC) a commercially available antioxidant, increases brain antioxidant levels and reduces the ‘dual hit’ brain injury associated with ischemia and infection in animal models.
In this work we will examine the brain injury in 125 babies with neonatal encephalopathy using serial (3) MR scans for charactering the evolution on the injury. In a sub group of 20 babies we will examine the physiological effects of intravenous N-acetyl administration on brain anti-oxidant level (glutathione) and neuronal integrity (N-acetyl aspartate level) using MR spectroscopy.
This work will unable us to characterise the brain injury due to co-existent infection in ischemia, and will inform the design next stage of the work that would examine these adjunct neuroprotectant therapy in a randomised controlled trial design.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1091
Date of REC Opinion
19 Aug 2015
REC opinion
Further Information Favourable Opinion