ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants (ePrime)
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|ClinicalTrials.gov Identifier: NCT01049594|
Recruitment Status : Unknown
Verified April 2010 by Imperial College London.
Recruitment status was: Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : June 3, 2015
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||625 participants|
|Official Title:||Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2015|
Delivery at less than 33 completed weeks of gestation
- This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants. [ Time Frame: 5 years ]
- Determine with high precision the sensitivity and specificity of cerebral MR imaging for predicting neurodevelopmental impairment in the context of the NHS.
- 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.
- Compare the influence of MR- and ultrasound-based information on parental perceptions, stress and coping.
- Compare routine local bedside with specialist centralised ultrasound imaging.
- Survey current MR use and capacity in the NHS.
- Develop further novel MR methods to predict neurodevelopmental impairment.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049594
|Croydon University Hospital|
|London, United Kingdom, CR7 7YE|
|Barnet General Hospital|
|London, United Kingdom, EN5 3DJ|
|Northwick Park Hospital|
|London, United Kingdom, HA1 3UJ|
|Kingston Hospital NHS Trust|
|London, United Kingdom, KT2 7QB|
|Guys & St Thomas NHS Trust Foundation|
|London, United Kingdom, SE1 7EH|
|Epsom and St Helier University Hospital|
|London, United Kingdom, SM5 1AA|
|St George's Healthcare NHS Trust|
|London, United Kingdom, SW17 0QT|
|West Middlesex University Hospital|
|London, United Kingdom, TW7 6AF|
|Ealing Hospital NHS Trust|
|London, United Kingdom, UB1 3HW|
|London, United Kingdom, UB8 3NN|
|Queen Charlotte's & Chelsea Hospital|
|London, United Kingdom, W12 0HS|
|St Marys Hospital|
|London, United Kingdom, W2 1NY|
|St. Peter's Hospital|
|Surrey, United Kingdom, KT16 0PZ|
|Principal Investigator:||David Edwards||Imperial College London|