Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT01721512
Status:
COMPLETED
Last Update Posted:
2012-11-05
First Post:
2012-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Growth and Development of Breast and Formula Fed Term Asian Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007774', 'term': 'Lactation'}, {'id': 'D041943', 'term': 'Infant Formula'}], 'ancestors': [{'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D049590', 'term': 'Postpartum Period'}, {'id': 'D041941', 'term': 'Milk Substitutes'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005526', 'term': 'Food, Formulated'}, {'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D007225', 'term': 'Infant Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Faecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-02', 'studyFirstSubmitDate': '2012-11-01', 'studyFirstSubmitQcDate': '2012-11-02', 'lastUpdatePostDateStruct': {'date': '2012-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant weight, body length head circumference', 'timeFrame': '12 months', 'description': 'Infant weight, body length head circumference at enrolment, 2 weeks, 4 weeks and monthly thereafter until 6 months, and then at 8, 10 and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal tolerance', 'timeFrame': '6 months', 'description': 'Gastrointestinal tolerance: stool frequency and consistency using Bristol Stool Chart monthly up to 6 months'}, {'measure': 'Indicators or formula tolerance', 'timeFrame': '12 months', 'description': 'Indicators or formula tolerance: crying, irritability, sleep patterns'}, {'measure': 'General health', 'timeFrame': '12 months', 'description': 'General health: any hospitalisation, doctor visits, symptoms of respiratory or gastrointestinal infection, fever, antibiotic and medication usage'}, {'measure': 'Gut integrity', 'timeFrame': '3 months', 'description': 'Gut integrity: faecal Alpha1-antitrypsin and faecal calprotectin'}, {'measure': 'Gut microflora', 'timeFrame': '3 months', 'description': 'Gut microflora: real time PCR'}, {'measure': 'Developmental progress', 'timeFrame': '12 months', 'description': 'Developmental progress: assessed by Ages and Stages'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Prospective observational study', 'Breast feeding', 'Infant formula', 'Infant', 'Indonesia'], 'conditions': ['Growth']}, 'referencesModule': {'references': [{'pmid': '25710823', 'type': 'DERIVED', 'citation': 'Dwipoerwantoro PG, Mansyur M, Oswari H, Makrides M, Cleghorn G, Firmansyah A. Growth of Indonesian Infants Compared With World Health Organization Growth Standards. J Pediatr Gastroenterol Nutr. 2015 Aug;61(2):248-52. doi: 10.1097/MPG.0000000000000770.'}]}, 'descriptionModule': {'briefSummary': 'Prospective cohort study of breast and formula fed infants in a suburban setting in Jakarta, Indonesia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Weeks', 'minimumAge': '2 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy infants recruited from Jati Padang, Pasar Minggu District, South Jakarta, Indonesia', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast-fed: 1. Mother intends to exclusively breast-feed from birth to at least 4 months; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg.\n* Formula-fed: 1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding; 2. A healthy term infant with gestational age fo 37-42 weeks and birth weight greater than or equal to 2.5 kg and equal or less than 4.75 kg; 3. Mother consents to her infant receiving trial infant formula for 12 months.\n\nExclusion Criteria:\n\n* 1\\. Severe congenital or metabolic disease likely to affect infant feeding or infant growth.\n* 2\\. Multiple birth'}, 'identificationModule': {'nctId': 'NCT01721512', 'briefTitle': 'The Growth and Development of Breast and Formula Fed Term Asian Infants', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Growth and Development of Breast and Formula Fed (Containing Synbiotics and LCPUFA) Term Asian Infants.', 'orgStudyIdInfo': {'id': 'Project Grow'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast-fed infants', 'description': '80 infants of mothers who plan to exclusively breastfeed for at least 6 months.', 'interventionNames': ['Other: Breastfeeding']}, {'label': 'Formula-fed infants', 'description': '1. Mother is exclusively feeding infant formula milk less than or equal to 6 weeks of birth and has no prospect of breastfeeding.\n2. Mother consents to her infant receiving trial infant formula for 12 months', 'interventionNames': ['Other: Infant formula']}], 'interventions': [{'name': 'Breastfeeding', 'type': 'OTHER', 'armGroupLabels': ['Breast-fed infants']}, {'name': 'Infant formula', 'type': 'OTHER', 'armGroupLabels': ['Formula-fed infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Universitas Indonesia', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Agus Firmansyah, Professor, MD, PhD, SpA(K)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fonterra Brands (Singapore) PTE LTD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chief, Division of Gastrohepatology, Department of Child Health, Medical Faculty, University of Indonesia', 'investigatorFullName': 'Prof. Agus Firmansyah, MD, Ph.D', 'investigatorAffiliation': 'Indonesia University'}}}}