Cerebral PalsyePrimeNCT01049594
ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
An observational study of Cerebral Palsy, run by Imperial College London at 13 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages Up to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- How many people
- 625 participants
- Where
- 13 sitesUnited Kingdom
- Study dates
- Apr 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- -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
Who cannot join
- Prior MR imaging
- Major Congenital Malformations
- Presence of Metallic Implants
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United Kingdom13 sites
Croydon University Hospital
London, CR7 7YE
Barnet General Hospital
London, EN5 3DJ
Northwick Park Hospital
London, HA1 3UJ
Kingston Hospital NHS Trust
London, KT2 7QB
Guys & St Thomas NHS Trust Foundation
London, SE1 7EH
Epsom and St Helier University Hospital
London, SM5 1AA
St George's Healthcare NHS Trust
London, SW17 0QT
West Middlesex University Hospital
London, TW7 6AF
Ealing Hospital NHS Trust
London, UB1 3HW
Hillingdon Hopsital
London, UB8 3NN
Queen Charlotte's & Chelsea Hospital
London, W12 0HS
St Marys Hospital
London, W2 1NY
St. Peter's Hospital
Surrey, KT16 0PZ
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm infants | Delivery at less than 33 completed weeks of gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 625 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Edwards, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049594
- Sponsor's protocol ID
- EudraCT 2009-011602-42
- Other IDs
- RP-PG-0707-10154
- Acronym
- ePrime
- Status last verified
- Apr 2010
- First submitted
- 13 Jan 2010
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28988160Harvey 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.
PubMed 28764800
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
- ClinicalTrials.gov ID
- NCT01049594
- Acronym / sponsor ID
- ePrime / EudraCT 2009-011602-42
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 625 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 14 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm infants | – | –Delivery at less than 33 completed weeks of gestation |
Who may qualify
- Ages
- Up to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (3 listed)
- Prior MR imaging
- Major Congenital Malformations
- Presence of Metallic Implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 28988160Edwards 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.
- Derived from this study: PubMed 28764800Harvey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Edwards principal investigator
Imperial College London
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Imperial College London at 13 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01049594, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.