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

Cerebral Palsy Clinical Trial

— ePrime  

Official title:

Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01049594
• Other study ID #: EudraCT 2009-011602-42
• Secondary ID: RP-PG-0707-10154
• Status: Active, not recruiting
• Phase: N/A
• First received: January 13, 2010
• Last updated: June 2, 2015
• Start date: April 2010
• Est. completion date: June 2015

Study information

• Verified date: April 2010
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 625
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 33 Weeks

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Palsy

Locations

Country	Name	City	State
United Kingdom	Barnet General Hospital	London
United Kingdom	Croydon University Hospital	London
United Kingdom	Ealing Hospital NHS Trust	London
United Kingdom	Epsom and St Helier University Hospital	London
United Kingdom	Guys & St Thomas NHS Trust Foundation	London
United Kingdom	Hillingdon Hopsital	London
United Kingdom	Kingston Hospital NHS Trust	London
United Kingdom	Northwick Park Hospital	London
United Kingdom	Queen Charlotte's & Chelsea Hospital	London
United Kingdom	St George's Healthcare NHS Trust	London
United Kingdom	St Marys Hospital	London
United Kingdom	West Middlesex University Hospital	London
United Kingdom	St. Peter's Hospital	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants.	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.	5 years	No