Healthy
Conditions
Keywords
infant, term birth, human milk, infant formula, breast feeding, bottle feeding, gastrointestinal tract, quality of life, infant development
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.
Interventions
OTHERStudy formula feeding
Infants who are exclusively fed the new study formula at time of enrollment
OTHERHuman milk feeding
Infants who are exclusively fed human milk at time of enrollment
OTHERMixed feeding
Infants who are exclusively fed human milk and the new study formula at time of enrollment
Sponsors
Société des Produits Nestlé (SPN)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Days to 49 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Infant stool consistency and frequency (assessed using a 3-day stool diary) | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Infant gastrointestinal tolerance (assessed using a validated, interviewer-assisted parent questionnaire) | Baseline |
| Infant and parent health-related quality of life (assessed using validated parent questionnaires) | Baseline |
Countries
China
Outcome results
None listed