Brain development in neonates born to mothers prescribed methadone. V1
Research type
Research Study
Full title
Advanced magnetic resonance imaging to investigate brain development of neonates born to opioid-dependent mothers who are prescribed methadone.
IRAS ID
163777
Contact name
James Boardman
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Background:
Substance misuse affects 243 million people globally. Pregnant women who use heroin are usually offered methadone (a synthetic opioid) as a substitute because it helps stabilise lifestyle, reduces the risk of preterm birth and poor growth of the baby in the womb.Methadone reaches the baby via the placenta. There are side effects for the exposed baby, with some newborns experiencing reduced growth and head size, drug withdrawal (neonatal abstinence syndrome), altered brain responses to stimuli, and some grow up to have learning difficulties in childhood. Scientists do not know whether these problems are due to methadone exposure in the womb or to events that occur after birth.
MRI is a safe technique that provides detailed pictures of the brain without exposure to ionizing radiation. Advanced MRI analysis techniques enable us to identify if there are any differences in brain volume, and / or the integrity of connections within the brain between the two groups.
Hypothesis:
Brain development is altered in newborns whose mothers were prescribed methadone compared with age matched controls whose mothers were not prescribed methadone.Methods:
30 babies exposed to methadone in the womb and 30 babies unexposed to methadone or other opiate drugs, matched for gestation and birthweight, will be recruited. They will undergo a single MRI scan of their brain. A comparison of brain structure and tissue integrity between the two groups will be performed..If brain development is altered in the offspring of women prescribed methadone then research attention should focus on the antenatal period for optimising outcomes, including consideration of alternative opiate substitutes. Buprenorphine is one such alternative with theoretic safety advantages over methadone for the fetus because it has lower placental transfer and a slightly lower potency. If there are no differences, research attention should focus on the postnatal period.
REC name
South East Scotland REC 02
REC reference
14/SS/1106
Date of REC Opinion
12 Jan 2015
REC opinion
Further Information Favourable Opinion