Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-04-21 @ 4:39 PM
Study NCT ID:
NCT03351595
Status:
UNKNOWN
Last Update Posted:
2017-11-27
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ewha Birth and Growth Study (Birth Cohort)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 734}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2001-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-23', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Profile of participants received regular medical check-up and result feed back for growth development', 'timeFrame': '365days', 'description': 'Changes from baseline in physical growth using anthropometric measurement'}], 'secondaryOutcomes': [{'measure': 'Profile of participants received blood pressure measurement for pediatric hypertension', 'timeFrame': '365days', 'description': 'Changes from baseline in average blood pressure(mmHg, diastolic and systolic) as above the 95th percentile adjusted for sex, age, and height percentile'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Growth pattern', 'Environmental and prenatal exposure'], 'conditions': ['Pediatric Health']}, 'descriptionModule': {'briefSummary': "Ongoing longitudinal birth cohort established at Mok-dong Hospital, Ewha Woman's University, Seoul, South Korea, between 2001 and 2006.", 'detailedDescription': 'Cohort composed of mothers, who visited to prenatal care between 24 and 28 weeks of gestation, between 2001 and 2006. After the child was born then, we collected information at birth outcome and conducted mail surveys at 6, 12, 18, and 24 months. Regular check-up was conducted at 3, 5, and every year after 7 years of age(last check up point: 15 years old). In check-up survey, after an 8-hour overnight fast, blood and urine samples (3 ml EDTA-blood and 5 ml serum) were obtained from subjects by venepuncture. following parameters were checked: physical growth, blood pressure. metabolic biomarker(Total cholesterol, HDl-cholesterol, TG(triglyceride), glucose, uric acid, etc.), K-CBCL(Korea-child behavior checklist), 24 hour recall method for nutrition, FFQ(Food Frequency Questionnaire), Questionnaires including Socio-economic status and physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '24 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Healthy infants and Participants' mothers", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants' mothers, who visited to prenatal care between 24 and 28 weeks of gestation.\n* An individual who can be followed up during the study period and is capable of complying with the study requirements\n\nExclusion Criteria:\n\n* An individual thought to have difficulty participating in the study due to other reasons, based on the judgment of the investigator"}, 'identificationModule': {'nctId': 'NCT03351595', 'briefTitle': 'Ewha Birth and Growth Study (Birth Cohort)', 'organization': {'class': 'OTHER', 'fullName': 'Ewha Womans University'}, 'officialTitle': 'Evaluation of Influencing Factors Affecting Childhood Metabolic Indicators in Korea (Repeated Measures Analysis; Longitudinal Birth Study)', 'orgStudyIdInfo': {'id': 'EWCS'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ewha Womans University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Foundation of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}