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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01370967
First received: June 8, 2011
Last updated: December 23, 2013
Last verified: December 2013
  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
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

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
Zhu Jiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510150
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, China
Nanfang 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
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Maternity and Child Health Care Hospital in Jiangsu Province
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
Children's Hospital of Fudan University
Shanghai, China
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200127
Sponsors and Collaborators
Nestlé
  More Information

Additional Information:
No publications provided

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 18, 2014