MARINAC Study
Research type
Research Study
Full title
Magnetic Resonance in Infection-Primed Neonatal Encephalopathy and N-acetyl cysteine
IRAS ID
177870
Contact name
Sudhin Thayyil
Contact email
Duration of Study in the UK
6 years, 0 months, 1 days
Research summary
Newborns who have had a period of low blood flow to the brain and have evidence of brain injury are at high risk for future movement problems called cerebral palsy, developmental delay (not walking or talking on time), or death. Whole body cooling may help your baby’s brain recover, but hypothermia has been shown to help only 1 in 8 infants who have brain injury due to neonatal encephalopathy (NE). About half of infants who have been cooled will still have significant developmental problems, such as motor, thinking, language, speech, hearing, or vision problems. The highest risk is for cerebral palsy, a movement disorder that causes weakness or abnormal movements in legs, arms and hands.
Infants with more acid in their blood and those with vitamin D deficiency are known to have worse neurodevelopment after brain injury.
N-acetylcysteine (NAC), an antioxidant, and Vitamin D increase brain antioxidant levels and decrease brain inflammation in animals and humans, and may help lessen severe motor problems in babies after a period of low blood flow to the brain. Both NAC and Vitamin D are approved by the FDA. NAC is used all over the world to treat neonates with liver failure or too much mucus in their lungs, and in older children who take too much acetaminophen (Tylenol). Vitamin D is given to all infants after birth. Both drugs are considered safe for sick infants.Absolute quantification of deep nuclei N-acetyl aspartate ([NAA]) is the best biomarker of neuronal integrity, and discriminates between varying grades of long-term disability. Despite its promise, the gold standard approach to acquire [NAA] takes unfeasibly long (30 minutes) to perform outside of a research environment.
The first part of the proposed work is to develop and validate a rapid proton MR spectroscopy to assess deep brain nuclei [NAA] in neonatal encephalopathy and to examine the effect of perinatal infection on neonatal brain injury. In the second part, we will evaluate the physiological responses to N-acetyl cysteine and Vitamin D.REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0763
Date of REC Opinion
22 May 2015
REC opinion
Unfavourable Opinion