Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
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ClinicalTrials.gov Identifier: NCT01370967 |
Recruitment Status
:
Completed
First Posted
: June 10, 2011
Last Update Posted
: December 24, 2013
|
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Condition or disease | Intervention/treatment |
---|---|
Healthy | Other: Study formula feeding Other: Human milk feeding Other: Mixed feeding |
Study Type : | Observational |
Actual Enrollment : | 460 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Group/Cohort | Intervention/treatment |
---|---|
Study formula-fed only |
Other: Study formula feeding
Infants who are exclusively fed the new study formula at time of enrollment
|
Human milk-fed only |
Other: Human milk feeding
Infants who are exclusively fed human milk at time of enrollment
|
Mixed-fed using study formula only |
Other: Mixed feeding
Infants who are exclusively fed human milk and the new study formula at time of enrollment
|
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: Baseline ]
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 15 ]
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 30 ]
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 45 ]
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: Baseline ]
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: day 18 ]
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: day 48 ]
- Infant and parent health-related quality of life (assessed using validated parent questionnaires) [ Time Frame: Baseline ]
- Infant and parent health-related quality of life (assessed using validated parent questionnaires) [ Time Frame: day 48 ]

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Ages Eligible for Study: | 35 Days to 49 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Healthy, term (37-42 weeks gestation), singleton infant at birth.
- 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:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370967
China, Beijing | |
The 306th Hospital of PLA | |
Chaoyang District, Beijing, China | |
Beijing Haidian Maternal&Child Health Hospital | |
Haidian District, Beijing, China | |
China, Chongqing | |
Children's Hospital of Chongqing Medical University | |
Yuzhong, Chongqing, China | |
China, Guangdong | |
Dongguan People's Hospital | |
Dongguan City, Guangdong, China | |
The First Affiliated Hospital, Sun Yat-Sen University | |
Guangzhou, Guangdong, China, 510150 | |
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 | |
China, Hunan | |
Changsha Hospital for Maternal&Child Health Care | |
Changsha, Hunan, China | |
China, Jiangsu | |
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 | |
China, Sichuan | |
Chengdu Women & Children Center Hospital | |
Chengdu, Sichuan, China | |
West China Second University Hospital, SCU | |
Chengdu, Sichuan, China | |
China, Tianjin | |
Tianjin First Center Hospital | |
Nankai, Tianjin, China | |
China, Zhejiang | |
Hangzhou First People's Hospital | |
Hangzhou, Zhejiang, China | |
Ningbo Yinzhou People's Hospital | |
Ningbo, Zhejiang, China | |
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, 200127 | |
Children's Hospital of Fudan University | |
Shanghai, China |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Nestlé |
ClinicalTrials.gov Identifier: | NCT01370967 History of Changes |
Other Study ID Numbers: |
B3611002 |
First Posted: | June 10, 2011 Key Record Dates |
Last Update Posted: | December 24, 2013 |
Last Verified: | December 2013 |
Keywords provided by Nestlé:
infant term birth human milk infant formula breast feeding |
bottle feeding gastrointestinal tract quality of life infant development |