Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-30 @ 10:58 AM
Study NCT ID:
NCT01049594
Status:
UNKNOWN
Last Update Posted:
2015-06-03
First Post:
2010-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples containing DNA.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 625}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2010-01-13', 'studyFirstSubmitQcDate': '2010-01-13', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '1. Determine with high precision the sensitivity and specificity of cerebral MR imaging for predicting neurodevelopmental impairment in the context of the NHS.\n2. 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.\n3. Compare the influence of MR- and ultrasound-based information on parental perceptions, stress and coping.\n4. Compare routine local bedside with specialist centralised ultrasound imaging.\n5. Survey current MR use and capacity in the NHS.\n6. Develop further novel MR methods to predict neurodevelopmental impairment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '28988160', 'type': 'DERIVED', '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.'}, {'pmid': '28764800', 'type': 'DERIVED', '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."}]}, 'descriptionModule': {'briefSummary': 'Preterm infants face an uncertain future because premature birth often leads to problems with brain development and can cause cerebral palsy.\n\nA 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.\n\nThis 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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '33 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-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\n\nExclusion Criteria:\n\n* Prior MR imaging\n* Major Congenital Malformations\n* Presence of Metallic Implants'}, 'identificationModule': {'nctId': 'NCT01049594', 'acronym': 'ePrime', 'briefTitle': 'ePrime: Evaluation of Magnetic Resonance (MR) Imaging to Predict Neurodevelopmental Impairment in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Evaluation of MR Imaging to Predict Neurodevelopmental Impairment in Preterm Infants', 'orgStudyIdInfo': {'id': 'EudraCT 2009-011602-42'}, 'secondaryIdInfos': [{'id': 'RP-PG-0707-10154', 'type': 'OTHER_GRANT', 'domain': 'The National Institute for Health Research'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infants', 'description': 'Delivery at less than 33 completed weeks of gestation'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CR7 7YE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Croydon University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'EN5 3DJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Barnet General Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'HA1 3UJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Northwick Park Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'KT2 7QB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Kingston Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE1 7EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Guys & St Thomas NHS Trust Foundation', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM5 1AA', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Epsom and St Helier University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': "St George's Healthcare NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'TW7 6AF', 'city': 'London', 'country': 'United Kingdom', 'facility': 'West Middlesex University Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'UB1 3HW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Ealing Hospital NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'UB8 3NN', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hillingdon Hopsital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': "Queen Charlotte's & Chelsea Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'St Marys Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'KT16 0PZ', 'city': 'Surrey', 'country': 'United Kingdom', 'facility': "St. Peter's Hospital"}], 'overallOfficials': [{'name': 'David Edwards', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}