Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
This study has been completed.
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01370967
First received: June 8, 2011
Last updated: December 23, 2013
Last verified: December 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Other: Study formula feeding Other: Human milk feeding Other: Mixed feeding |
Phase 4 |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Nestlé:
Primary Outcome Measures:
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 15 ] [ Designated as safety issue: No ]
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 30 ] [ Designated as safety issue: No ]
- Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 45 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: day 18 ] [ Designated as safety issue: No ]
- Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: day 48 ] [ Designated as safety issue: No ]
- Infant and parent health-related quality of life (assessed using validated parent questionnaires) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Infant and parent health-related quality of life (assessed using validated parent questionnaires) [ Time Frame: day 48 ] [ Designated as safety issue: No ]
| Enrollment: | 460 |
| Study Start Date: | July 2011 |
| Study Completion Date: | July 2013 |
| Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
Parents / legally acceptable representatives of eligible infants will be invited to volunteer.
Eligibility| Ages Eligible for Study: | 35 Days to 49 Days (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
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).
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370967
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370967
Locations
| 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 | |
Sponsors and Collaborators
Nestlé
More Information
Additional Information:
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01370967 History of Changes |
| Other Study ID Numbers: | B3611002 |
| Study First Received: | June 8, 2011 |
| Last Updated: | December 23, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Nestlé:
|
infant term birth human milk infant formula breast feeding |
bottle feeding gastrointestinal tract quality of life infant development |
ClinicalTrials.gov processed this record on September 23, 2016