Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
NCT ID: NCT01370967
Last Updated: 2013-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
460 participants
OBSERVATIONAL
2011-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Study formula-fed only
Study formula feeding
Infants who are exclusively fed the new study formula at time of enrollment
Human milk-fed only
Human milk feeding
Infants who are exclusively fed human milk at time of enrollment
Mixed-fed using study formula only
Mixed feeding
Infants who are exclusively fed human milk and the new study formula at time of enrollment
Interventions
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Study formula feeding
Infants who are exclusively fed the new study formula at time of enrollment
Human milk feeding
Infants who are exclusively fed human milk at time of enrollment
Mixed feeding
Infants who are exclusively fed human milk and the new study formula at time of enrollment
Eligibility Criteria
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Inclusion Criteria
* Post-natal age between 35 and 49 days (date of birth = day 0) at time of study entry.
* At enrollment, weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables / charts.
Exclusion Criteria
* 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.
35 Days
49 Days
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Locations
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The 306th Hospital of PLA
Chaoyang District, Beijing Municipality, China
Beijing Haidian Maternal&Child Health Hospital
Haidian District, Beijing Municipality, China
Children's Hospital of Chongqing Medical University
Yuzhong, Chongqing Municipality, China
Dongguan People's Hospital
Dongguan, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Zhu Jiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
Zhongshan Bo'ai Hospital
Zhongshan, Guangdong, China
Changsha Hospital for Maternal&Child Health Care
Changsha, Hunan, China
Maternity and Child Health Care Hospital in Jiangsu Province
Nanjing, Jiangsu, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Chengdu Women & Children Center Hospital
Chengdu, Sichuan, China
West China Second University Hospital, SCU
Chengdu, Sichuan, China
Tianjin First Center Hospital
Nankai, Tianjin Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Ningbo Yinzhou People's Hospital
Ningbo, Zhejiang, China
Beijing Obstetrics Gynecology Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Children's Hospital of Fudan University
Shanghai, , China
Countries
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References
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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.
Related Links
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Other Identifiers
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B3611002
Identifier Type: -
Identifier Source: org_study_id