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

Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula: A Prospective, Observational Cohort Study In China

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 460

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Beijing Obstetrics Gynecology Hospital
  • Shanghai, China
    • Children's Hospital of Fudan University
  • Shanghai, China, 200127
    • Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
  • Beijing
    • Chaoyang District, Beijing, China
      • The 306th Hospital of PLA
    • Haidian District, Beijing, China
      • Beijing Haidian Maternal&Child Health Hospital
  • Chongqing
    • Yuzhong, Chongqing, China
      • Children's Hospital of Chongqing Medical University
  • Guangdong
    • Dongguan City, Guangdong, China
      • Dongguan People's Hospital
    • Guangzhou, Guangdong, China
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China
      • The Third Affiliated Hospital of Guangzhou Medical University
    • Guangzhou, Guangdong, China
      • Guangzhou Women And Children's Medical Center
    • Guangzhou, Guangdong, China, 510150
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Zhu Jiang Hospital of Southern Medical University
    • Shantou, Guangdong, China
      • Shantou Central Hospital
    • Zhongshan, Guangdong, China
      • Zhongshan Bo'ai Hospital
  • Hunan
    • Changsha, Hunan, China
      • Changsha Hospital for Maternal&Child Health Care
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Maternity and Child Health Care Hospital in Jiangsu Province
    • Nanjing, Jiangsu, China
      • Nanjing Maternity and Child Health Care Hospital
    • Suzhou, Jiangsu, China
      • Suzhou Municipal Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Women & Children Center Hospital
    • Chengdu, Sichuan, China
      • West China Second University Hospital, SCU
  • Tianjin
    • Nankai, Tianjin, China
      • Tianjin First Center Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Hangzhou First People's Hospital
    • Ningbo, Zhejiang, China
      • Ningbo Yinzhou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Nestlé

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 8, 2011
• First Submitted That Met QC Criteria: June 8, 2011
• First Posted (Estimate): June 10, 2011

Study Record Updates

• Last Update Posted (Estimate): December 24, 2013
• Last Update Submitted That Met QC Criteria: December 23, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: quality of life; infant; human milk; breast feeding; infant formula; bottle feeding; gastrointestinal tract; infant development; term birth
• Other Study ID Numbers: B3611002