Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT04655820
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2020-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal and Infant Health and Breast Milk Study in South China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples and breast milk samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-03', 'studyFirstSubmitDate': '2020-11-01', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of nutrients in breast milk samples', 'timeFrame': '14 months', 'description': 'The nutrients were detected from breast milk samples of mothers by chemical analysis'}, {'measure': 'The level of nutrients in blood samples', 'timeFrame': '14 months', 'description': 'The nutrients were detected from blood samples of mothers and infants by chemical analysis'}], 'secondaryOutcomes': [{'measure': 'General demographic materials', 'timeFrame': '14 months', 'description': 'The general demographic materials of mothers were obtained by questionnaire or medical treatment records'}, {'measure': 'Dietary and lifestyle information', 'timeFrame': '14 months', 'description': 'Dietary and lifestyle information of mothers were obtained by Food Frequency Questionnaire and 24-hour meal review questionnaire'}, {'measure': 'Health follow-up', 'timeFrame': '14 months', 'description': 'Dietary and health outcome of infants were obtained by questionnaire or medical treatment records'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate the nutrients in breast milk of Chinese mothers and its related factors, as well as exploring the early development of infants.', 'detailedDescription': 'Breast milk contains a variety of nutrients that are beneficial to the early development of infants, such as lipids, Vitamins and so on. At present, the level of these nutrients in milk and infant formula are lower and which are present in a different form from that in breast milk. Therefore, this study was designed to investigate the level of nutrients in breast milk of Chinese mothers and learn about its related factors, as well as exploring the relationships between these nutrients and the early development of infants.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women and breast-feeding mothers of this study were recruited from Clifford Hospital during the perinatal period or lactation period', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 20-45 years\n* natural delivery, singleton pregnancy\n* healthy term infants（at 37-42 weeks of pregnancy）\n* don't smoke and drink\n* self-evaluation as physical health\n* breastfeeding at least until three months of age\n* Apgar score \\> 8\n* sign informed consent\n\nExclusion Criteria:\n\n* suffering from mastitis\n* gestational diabetes, hypertension and other metabolic diseases\n* AIDS, tuberculosis and other acute or chronic infectious diseases\n* severe heart and kidney diseases\n* mental system diseases\n* cancer and other malignant consumptive disease\n* take drugs that affect nutrient metabolism\n* infants with congenital and genetic diseases\n* with lactation contraindications\n* don't agree to sign informed consent"}, 'identificationModule': {'nctId': 'NCT04655820', 'briefTitle': 'Maternal and Infant Health and Breast Milk Study in South China', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Maternal and Infant Health and Breast Milk Study in South China', 'orgStudyIdInfo': {'id': 'HM-2020'}}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'SunYat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Huilian Zhu', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}