Clinical trial NCT01049594: ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
Official title: Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Palsy
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 625
Sex: ALL
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: This programme will provide the evidence-base for NHS policy on the use of magnetic resonance (MR) imaging of the brain for preterm infants.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Croydon University Hospital
city: London
country: United Kingdom
facility: Barnet General Hospital
city: London
country: United Kingdom
facility: Northwick Park Hospital
city: London
country: United Kingdom
facility: Kingston Hospital NHS Trust
city: London
country: United Kingdom
facility: Guys & St Thomas NHS Trust Foundation
city: London
country: United Kingdom
facility: Epsom and St Helier University Hospital
city: London
country: United Kingdom
facility: St George's Healthcare NHS Trust
city: London
country: United Kingdom
facility: West Middlesex University Hospital
city: London
country: United Kingdom
facility: Ealing Hospital NHS Trust
city: London
country: United Kingdom
facility: Hillingdon Hopsital
city: London
country: United Kingdom
facility: Queen Charlotte's & Chelsea Hospital
city: London
country: United Kingdom
facility: St Marys Hospital
city: Surrey
country: United Kingdom
facility: St. Peter's Hospital
Study officials:
affiliation: Imperial College London
name: David Edwards
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Harvey 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.