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

Completed
Conditions
Healthy
Registration Number
NCT01370967
Lead Sponsor
Société des Produits Nestlé (SPN)
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.

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
460
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Infant stool consistency and frequency (assessed using a 3-day stool diary)day 45
Secondary Outcome Measures
NameTimeMethod
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)day 48

Trial Locations

Locations (24)

The 306th Hospital of PLA

🇨🇳

Chaoyang District, Beijing, China

Beijing Haidian Maternal&Child Health Hospital

🇨🇳

Haidian District, Beijing, China

Children's Hospital of Chongqing Medical University

🇨🇳

Yuzhong, Chongqing, China

Dongguan People's Hospital

🇨🇳

Dongguan City, Guangdong, China

The First Affiliated Hospital, Sun Yat-Sen University

🇨🇳

Guangzhou, Guangdong, China

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

Scroll for more (14 remaining)
The 306th Hospital of PLA
🇨🇳Chaoyang District, Beijing, China

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