Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-01 @ 9:34 AM
Study NCT ID:
NCT02741934
Status:
COMPLETED
Last Update Posted:
2017-10-16
First Post:
2016-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-13', 'studyFirstSubmitDate': '2016-04-13', 'studyFirstSubmitQcDate': '2016-04-15', 'lastUpdatePostDateStruct': {'date': '2017-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function test', 'timeFrame': '8 Years old'}], 'secondaryOutcomes': [{'measure': 'Brain MRI', 'timeFrame': '8 Years old'}, {'measure': 'Korean Child Behavior Checklist', 'timeFrame': '8 Years old'}, {'measure': 'Korean ADHD Rating Scale-IV', 'timeFrame': '8 Years old'}, {'measure': 'Wechsler Scale of Intelligence-IV', 'timeFrame': '8 Years old'}, {'measure': 'Advanced Test of Attention', 'timeFrame': '8 Years old'}, {'measure': "Children's color trails test", 'timeFrame': '8 Years old'}, {'measure': 'STROOP', 'timeFrame': '8 Years old'}, {'measure': 'Wisconsin Card Sorting Test', 'timeFrame': '8 Years old'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Very Low Birth Weight Infants']}, 'descriptionModule': {'briefSummary': 'This study evaluates the cognitive and behavioral outcomes including image findings of school-aged children who were born preterm compared with who were born term gestational age.', 'detailedDescription': 'There are lots of studies published that school-aged children who were born preterm has some behavioral problems in school and they also have poor academical achievement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Among the infants who were born and admitted to Seoul National University Hospital from 2008 to 2009, the birth weight of the infants less than 1,500g or gestational age less than 32 weeks patients were enrolled.\n\nThe infants who were born from 2008 to 2009 with term gestational age will also be enrolled.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children former preterm infants \\< 32 weeks of gestation or 1,500gm of birth weight\n* children former normal term infants\n\nExclusion Criteria:\n\n* major congenital anomaly\n* neuromuscular disease\n* chromosomal anomaly'}, 'identificationModule': {'nctId': 'NCT02741934', 'briefTitle': 'Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Cognitive and Behavioral Outcomes of School-aged Children Who Were Born Preterm', 'orgStudyIdInfo': {'id': '2015-1927'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm cohort', 'description': 'Among the infants who were born and admitted to Seoul National University Hospital from 2008 to 2009, the birth weight of the infants less than 1,500g or gestational age less than 32 weeks patients were enrolled.'}, {'label': 'Term control cohort', 'description': 'The infants who were born from 2008 to 2009 with term gestational age will be enrolled.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'KangWon National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical associate professor', 'investigatorFullName': 'Ee-Kyung Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}