Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment
Healthy	Other: Study formula feeding; Other: Human milk feeding; Other: Mixed feeding

Detailed Description:

Parents / legally acceptable representatives of eligible infants will be invited to volunteer.

Study Design

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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

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: Baseline ]
2. Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 15 ]
3. Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 30 ]
4. Infant stool consistency and frequency (assessed using a 3-day stool diary) [ Time Frame: day 45 ]

Secondary Outcome Measures :

1. Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: Baseline ]
2. Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: day 18 ]
3. Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) [ Time Frame: day 48 ]
4. Infant and parent health-related quality of life (assessed using validated parent questionnaires) [ Time Frame: Baseline ]
5. Infant and parent health-related quality of life (assessed using validated parent questionnaires) [ Time Frame: day 48 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	35 Days to 49 Days (Child)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Nestlé
ClinicalTrials.gov Identifier:	NCT01370967 History of Changes
Other Study ID Numbers:	B3611002
First Posted:	June 10, 2011
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