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

Nestlé

Status

Completed

Conditions

Healthy

Treatments

Other: Human milk feeding

Other: Mixed feeding

Other: Study formula feeding

Study type

Observational

Funder types

Industry

Identifiers

NCT01370967

B3611002

Details and patient eligibility

About

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.

Full description

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

Enrollment

460 patients

Sex

All

Ages

35 to 49 days old

Volunteers

Accepts Healthy Volunteers

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.