Gastrointestinal Tolerance And General Health Status Of Healthy Term Infants Fed A New Infant Formula
- 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
- 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.
- 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
Name Time Method Infant stool consistency and frequency (assessed using a 3-day stool diary) day 45
- Secondary Outcome Measures
Name Time Method 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
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