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Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
Preterm infants face an uncertain future because premature birth often leads to problems with brain development and can cause cerebral palsy. A trial needs to be done to see if Magnetic Resonance Imaging (MRI) helps families and professionals by predicting long term problems more accurately, allowing better targeting of care to children with problems and reassuring the parents of normal babies. This programme will provide the evidence-base for the National Health System (NHS) policy on the use of magnetic resonance imaging of the brain for preterm infants.
The trial will determine very accurately how well MRI predicts long-term problems, and it will assess whether it makes parents more or less anxious about their babies, and whether they seek more or less help in the first couple of years after birth,and see if the total cost to the NHS is increased by using MRI. It will also check up if there is a better way to do ultrasound examinations, and do a survey to see how much MRI is used in the United Kingdon (UK) and whether hospitals think they could provide it. The core of the project is a study of preterm babies who will be referred to a specialist centre to have both ultrasound and MRI scans. Half the parents will be told the results of the MRI and half the parents the ultrasound. The programme will then ask them to fill in questionnaires or be interviewed about their stress levels and the amount of support they seek for their children until they are two years old, when the babies will be examined to see if MRI predicted their outcome accurately.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Croydon University Hospital
London, United Kingdom
Barnet General Hospital
London, United Kingdom
Northwick Park Hospital
London, United Kingdom
Kingston Hospital NHS Trust
London, United Kingdom
Guys & St Thomas NHS Trust Foundation
London, United Kingdom
Epsom and St Helier University Hospital
London, United Kingdom
St George's Healthcare NHS Trust
London, United Kingdom
West Middlesex University Hospital
London, United Kingdom
Ealing Hospital NHS Trust
London, United Kingdom
Hillingdon Hopsital
London, United Kingdom
Start Date
April 1, 2010
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2015
Last Updated
June 3, 2015
625
ESTIMATED participants
Lead Sponsor
Imperial College London
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07168577