ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
ePrime
Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
2 other identifiers
observational
625
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2010
CompletedFirst Posted
Study publicly available on registry
January 14, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 3, 2015
April 1, 2010
5.2 years
January 13, 2010
June 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants.
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
Study Arms (1)
Preterm infants
Delivery at less than 33 completed weeks of gestation
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Prior MR imaging
- Major Congenital Malformations
- Presence of Metallic Implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Croydon University Hospital
London, CR7 7YE, United Kingdom
Barnet General Hospital
London, EN5 3DJ, United Kingdom
Northwick Park Hospital
London, HA1 3UJ, United Kingdom
Kingston Hospital NHS Trust
London, KT2 7QB, United Kingdom
Guys & St Thomas NHS Trust Foundation
London, SE1 7EH, United Kingdom
Epsom and St Helier University Hospital
London, SM5 1AA, United Kingdom
St George's Healthcare NHS Trust
London, SW17 0QT, United Kingdom
West Middlesex University Hospital
London, TW7 6AF, United Kingdom
Ealing Hospital NHS Trust
London, UB1 3HW, United Kingdom
Hillingdon Hopsital
London, UB8 3NN, United Kingdom
Queen Charlotte's & Chelsea Hospital
London, W12 0HS, United Kingdom
St Marys Hospital
London, W2 1NY, United Kingdom
St. Peter's Hospital
Surrey, KT16 0PZ, United Kingdom
Related Publications (2)
Edwards AD, Redshaw ME, Kennea N, Rivero-Arias O, Gonzales-Cinca N, Nongena P, Ederies M, Falconer S, Chew A, Omar O, Hardy P, Harvey ME, Eddama O, Hayward N, Wurie J, Azzopardi D, Rutherford MA, Counsell S; ePrime Investigators. Effect of MRI on preterm infants and their families: a randomised trial with nested diagnostic and economic evaluation. Arch Dis Child Fetal Neonatal Ed. 2018 Jan;103(1):F15-F21. doi: 10.1136/archdischild-2017-313102. Epub 2017 Oct 7.
PMID: 28988160DERIVEDHarvey M, Nongena P, Edwards D, Redshaw M. 'We knew it was a totally at random thing': parents' experiences of being part of a neonatal trial. Trials. 2017 Aug 1;18(1):361. doi: 10.1186/s13063-017-2112-3.
PMID: 28764800DERIVED
Biospecimen
Saliva samples containing DNA.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Edwards
Imperial College London
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2010
First Posted
January 14, 2010
Study Start
April 1, 2010
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
June 3, 2015
Record last verified: 2010-04