MERIDIAN 2-3 year follow up study
Research type
Research Study
Full title
Magnetic Resonance Imaging to Enhance the Diagnosis of Foetal Developmental Brain abnormalities in Utero 2-3 year follow up study.
IRAS ID
180504
Contact name
Paul Griffiths
Contact email
ISRCTN Number
ISRCTN27626961
Clinicaltrials.gov Identifier
144460, URMS (University Research Management System)
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
The proposed study is a follow on to the MERIDIAN study and has the following goals:
a) To update and improve the MERIDIAN primary outcome data using updated reference standards.
b) To refine the information given to pregnant women by collecting developmental outcome data on children in MERIDIAN.
Objective a) will be achieved by refreshing the post-natal imaging information using any neuroimaging performed by the age of 3 years. Reference data in the original MERIDIAN was based on any post-natal imaging performed before 6 months of age. We did not have access to follow up data in 182 of the original group primarily because no imaging had been performed before 6 months. There were many children who had cranial ultrasound examinations in the neonatal period that suggested further imaging that had not been performed within the timescale. This will allow us to obtain a large proportion of missing data and refine the existing estimates of diagnostic confidence and accuracy.
Objective b) can be best explained by example. Ventriculomegaly is the commonest referral for fetal brain imaging (2-3/1000 pregnancies) and is most frequently ‘mild’ (10-12mm). Most authorities tell women that there is a 10% risk of poor outcome if the fetal imaging is based on ultrasonography only. We believe that many of that 10% will be cases in which in utero MR shows another brain abnormality not recognised on ultrasonography. In which case, a fetus with true isolated mild ventriculomegaly will have a much reduced risk of poor outcome.
We will be able to test this supposition and hence alter the information given to pregnant women. Parallel arguments are made for other brain abnormalities.Future work:
We envisage that this is the first stage of a program of post-natal work as described in ‘Scientific Justification’.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
15/YH/0398
Date of REC Opinion
28 Sep 2015
REC opinion
Further Information Favourable Opinion