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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.
Parents / legally acceptable representatives of eligible infants will be invited to volunteer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study formula-fed only |
| ||
| Human milk-fed only |
| ||
| Mixed-fed using study formula only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study formula feeding | Other | Infants who are exclusively fed the new study formula at time of enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infant stool consistency and frequency (assessed using a 3-day stool diary) | Baseline | |
| Infant stool consistency and frequency (assessed using a 3-day stool diary) | day 15 | |
| Infant stool consistency and frequency (assessed using a 3-day stool diary) | day 30 | |
| Infant stool consistency and frequency (assessed using a 3-day stool diary) | day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) | Baseline | |
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) | day 18 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 306th Hospital of PLA | Chaoyang District | Beijing Municipality | China | |||
| Beijing Haidian Maternal&Child Health Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27502768 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Human milk feeding | Other | Infants who are exclusively fed human milk at time of enrollment |
|
| Mixed feeding | Other | Infants who are exclusively fed human milk and the new study formula at time of enrollment |
|
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) | day 48 |
| Infant and parent health-related quality of life (assessed using validated parent questionnaires) | Baseline |
| Infant and parent health-related quality of life (assessed using validated parent questionnaires) | day 48 |
| 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 | 510150 | 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 | 200127 | China |
| Children's Hospital of Fudan University | Shanghai | China |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D001903 | Bottle Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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