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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01049594
First received: January 13, 2010
Last updated: March 19, 2014
Last verified: April 2010
  Purpose

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
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Saliva samples containing DNA.


Estimated Enrollment: 625
Study Start Date: April 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Preterm infants
Delivery at less than 33 completed weeks of gestation

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.

  Eligibility

Ages Eligible for Study:   up to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01049594

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

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01049594     History of Changes
Other Study ID Numbers: EudraCT 2009-011602-42, RP-PG-0707-10154
Study First Received: January 13, 2010
Last Updated: March 19, 2014
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014