Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-28 @ 4:57 AM
Study NCT ID:
NCT01370967
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2011-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D001903', 'term': 'Bottle Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2011-06-08', 'studyFirstSubmitQcDate': '2011-06-08', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Infant stool consistency and frequency (assessed using a 3-day stool diary)', 'timeFrame': 'Baseline'}, {'measure': 'Infant stool consistency and frequency (assessed using a 3-day stool diary)', 'timeFrame': 'day 15'}, {'measure': 'Infant stool consistency and frequency (assessed using a 3-day stool diary)', 'timeFrame': 'day 30'}, {'measure': 'Infant stool consistency and frequency (assessed using a 3-day stool diary)', 'timeFrame': 'day 45'}], 'secondaryOutcomes': [{'measure': 'Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)', 'timeFrame': 'Baseline'}, {'measure': 'Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)', 'timeFrame': 'day 18'}, {'measure': 'Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire)', 'timeFrame': 'day 48'}, {'measure': 'Infant and parent health-related quality of life (assessed using validated parent questionnaires)', 'timeFrame': 'Baseline'}, {'measure': 'Infant and parent health-related quality of life (assessed using validated parent questionnaires)', 'timeFrame': 'day 48'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['infant', 'term birth', 'human milk', 'infant formula', 'breast feeding', 'bottle feeding', 'gastrointestinal tract', 'quality of life', 'infant development'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '27502768', 'type': 'DERIVED', 'citation': 'Hays NP, Mao M, Zhang L, Ge J, Northington R, Yao M, Volger S. Infant feeding and health-related quality of life in healthy Chinese infants: results from a prospective, observational cohort study. Health Qual Life Outcomes. 2016 Aug 8;14(1):116. doi: 10.1186/s12955-016-0518-3.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3611002&StudyName=Gastrointestinal%20Tolerance%20And%20General%20Health%20Status%20Of%20Healthy%20Term%20Infants%20Fed%20A%20New%20Infant%20Formula', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess stool consistency, in combination with additional health-related parameters including gastrointestinal tolerance and health-related quality of life, in a large sample of Chinese infants. We will also assess the timing of, frequency, and reasons for changes in the choice of formula or method of feeding among infants in this sample, as well as incidence of common infant illness and associated healthcare usage. Anthropometric measures and the frequency and duration of physician- and parent-reported gastrointestinal and other adverse events will be evaluated.', 'detailedDescription': 'Parents / legally acceptable representatives of eligible infants will be invited to volunteer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '49 Days', 'minimumAge': '35 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy term infants aged approximately 42 days (range 35 - 49 days) who are brought to the health clinic for their first normally-scheduled well-baby visit (i.e. typically age 42 days in China).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, term (37-42 weeks gestation), singleton infant at birth.\n* Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.\n* At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.\n\nExclusion Criteria:\n\n* Infants who are consuming any types/brands of formula other than the new study formula (either exclusively or in a mixed feeding regimen) at time of study enrollment.\n* Suspected or documented severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the infant inappropriate for entry into the study.'}, 'identificationModule': {'nctId': 'NCT01370967', 'briefTitle': 'Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China', 'orgStudyIdInfo': {'id': 'B3611002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study formula-fed only', 'interventionNames': ['Other: Study formula feeding']}, {'label': 'Human milk-fed only', 'interventionNames': ['Other: Human milk feeding']}, {'label': 'Mixed-fed using study formula only', 'interventionNames': ['Other: Mixed feeding']}], 'interventions': [{'name': 'Study formula feeding', 'type': 'OTHER', 'description': 'Infants who are exclusively fed the new study formula at time of enrollment', 'armGroupLabels': ['Study formula-fed only']}, {'name': 'Human milk feeding', 'type': 'OTHER', 'description': 'Infants who are exclusively fed human milk at time of enrollment', 'armGroupLabels': ['Human milk-fed only']}, {'name': 'Mixed feeding', 'type': 'OTHER', 'description': 'Infants who are exclusively fed human milk and the new study formula at time of enrollment', 'armGroupLabels': ['Mixed-fed using study formula only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chaoyang District', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'The 306th Hospital of PLA'}, {'city': 'Haidian District', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Haidian Maternal&Child Health Hospital'}, {'city': 'Yuzhong', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': "Children's Hospital of Chongqing Medical University"}, {'city': 'Dongguan', 'state': 'Guangdong', 'country': 'China', 'facility': "Dongguan People's Hospital", 'geoPoint': {'lat': 23.01797, 'lon': 113.74866}}, {'zip': '510150', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': "Guangzhou Women and Children's Medical Center", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The Third Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Zhu Jiang Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Shantou Central Hospital', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'city': 'Zhongshan', 'state': 'Guangdong', 'country': 'China', 'facility': "Zhongshan Bo'ai Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Changsha Hospital for Maternal&Child Health Care', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Maternity and Child Health Care Hospital in Jiangsu Province', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing Maternity and Child Health Care Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Suzhou Municipal Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Chengdu Women & Children Center Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Second University Hospital, SCU', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Nankai', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin First Center Hospital', 'geoPoint': {'lat': 38.98278, 'lon': 117.59917}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Hangzhou First People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': "Ningbo Yinzhou People's Hospital", 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Obstetrics Gynecology Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}