ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants (ePrime)

June 2, 2015 updated by: Imperial College London

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

625

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0QT
        • St George's Healthcare NHS Trust
      • London, United Kingdom, W2 1NY
        • St Marys Hospital
      • London, United Kingdom, HA1 3UJ
        • Northwick Park Hospital
      • London, United Kingdom, EN5 3DJ
        • Barnet General Hospital
      • London, United Kingdom, CR7 7YE
        • Croydon University Hospital
      • London, United Kingdom, KT2 7QB
        • Kingston Hospital NHS Trust
      • London, United Kingdom, SE1 7EH
        • Guys & St Thomas NHS Trust Foundation
      • London, United Kingdom, SM5 1AA
        • Epsom and St Helier University Hospital
      • London, United Kingdom, TW7 6AF
        • West Middlesex University Hospital
      • London, United Kingdom, UB1 3HW
        • Ealing Hospital NHS Trust
      • London, United Kingdom, UB8 3NN
        • Hillingdon Hopsital
      • London, United Kingdom, W12 0HS
        • Queen Charlotte's & Chelsea Hospital
      • Surrey, United Kingdom, KT16 0PZ
        • St. Peter's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants delivered at less than 33 weeks of gestation. The North and South west London Perinatal Networks will provide a representative sample of the preterm infants cared for by the NHS.

Description

Inclusion Criteria:

-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

Exclusion Criteria:

  • Prior MR imaging
  • Major Congenital Malformations
  • Presence of Metallic Implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preterm infants
Delivery at less than 33 completed weeks of gestation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
  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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: David Edwards, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

January 13, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimate)

January 14, 2010

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT 2009-011602-42
  • RP-PG-0707-10154 (Other Grant/Funding Number: The National Institute for Health Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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