Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-25 @ 6:53 PM
Study NCT ID:
NCT01822067
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2013-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Maternal Body Composition on Offspring Brain Structure and Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2013-02-26', 'studyFirstSubmitQcDate': '2013-04-01', 'lastUpdatePostDateStruct': {'date': '2025-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Structure', 'timeFrame': 'Age 2 weeks', 'description': 'We will use high resolution volumetric magnetic resonance imaging (MRI) and Diffusion tensor imaging (DTI) to measure the brain structure of 2 week old infants'}], 'secondaryOutcomes': [{'measure': 'Brain Function', 'timeFrame': 'Age 2 weeks', 'description': 'We will use high resolution Resting state functional magnetic resonance imaging (rsfMRI) to measure the brain function of 2 week old infants'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Brain Function']}, 'descriptionModule': {'briefSummary': 'The specific aim of this study is to use MRI methods to evaluate and compare brain structure and function in two groups of full-term neonates at two-weeks of age: those born of obese mothers and those born to normal weight mothers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Days', 'minimumAge': '11 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Full term neonates born from obese or lean mothers enrolled in the Glowing study (IRB#110889)', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* the participant must be enrolled in the Arkansas Children's Nutrition Center (ACNC) Glowing study and be about 2 weeks of age +/- 3days\n\nExclusion Criteria:\n\n* none specified"}, 'identificationModule': {'nctId': 'NCT01822067', 'briefTitle': 'Effects of Maternal Body Composition on Offspring Brain Structure and Function', 'organization': {'class': 'OTHER', 'fullName': "Arkansas Children's Hospital Research Institute"}, 'officialTitle': 'Effects of Maternal Body Composition on Offspring Brain Structure and Function', 'orgStudyIdInfo': {'id': '134776'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal weight- Non Maternal obesity', 'description': 'Full-term neonates at 2 weeks of age born to normal weight mothers'}, {'label': 'Obese- Obese Mothers', 'description': 'Full-term neonates at two weeks of age born of obese mothers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72203', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': "Arkansas Children's Nutrition Center", 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Xiawei Ou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Arkansas Children's Nutrition Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Arkansas Children's Hospital Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}