ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
- Conditions
- Cerebral Palsy
- Registration Number
- NCT01049594
- Lead Sponsor
- Imperial College London
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 625
-Delivery at less than 33 completed weeks of gestation, estimated from early fetal ultrasonographic measurements as recommended in the National Institute of Clinical Excellence Guidelines: Antenatal Care for the Healthy Woman
- Prior MR imaging
- Major Congenital Malformations
- Presence of Metallic Implants
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants. 5 years 1. Determine with high precision the sensitivity and specificity of cerebral MR imaging for predicting neurodevelopmental impairment in the context of the NHS.
2. Use a randomised design to compare the effect of MR and ultrasound imaging on total healthcare usage and costs, and assess its effect on unplanned and planned care.
3. Compare the influence of MR- and ultrasound-based information on parental perceptions, stress and coping.
4. Compare routine local bedside with specialist centralised ultrasound imaging.
5. Survey current MR use and capacity in the NHS.
6. Develop further novel MR methods to predict neurodevelopmental impairment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
Northwick Park Hospital
🇬🇧London, United Kingdom
Barnet General Hospital
🇬🇧London, United Kingdom
Kingston Hospital NHS Trust
🇬🇧London, United Kingdom
St George's Healthcare NHS Trust
🇬🇧London, United Kingdom
Queen Charlotte's & Chelsea Hospital
🇬🇧London, United Kingdom
Croydon University Hospital
🇬🇧London, United Kingdom
West Middlesex University Hospital
🇬🇧London, United Kingdom
Guys & St Thomas NHS Trust Foundation
🇬🇧London, United Kingdom
Ealing Hospital NHS Trust
🇬🇧London, United Kingdom
Epsom and St Helier University Hospital
🇬🇧London, United Kingdom
Hillingdon Hopsital
🇬🇧London, United Kingdom
St. Peter's Hospital
🇬🇧Surrey, United Kingdom
St Marys Hospital
🇬🇧London, United Kingdom