growth, weight gain, anthropometry, gastrointestinal comfort, safety, suitability, hydrolysate, intact protein, infant formula
Conditions
Sponsors
FrieslandCampina
Eligibility
Inclusion criteria
Inclusion criteria: • Full-term, healthy infants (born at gestational age ≥37 weeks). • Appropriate for gestational age birthweight (i.e. 10th centile ≤ Birth weight ≤ 90th centile) • Boys and girls • Age at enrolment (baseline measurement): between 55 and 80 days of age • Exclusively formula fed 2 weeks before inclusion • Exclusively formula fed during the entire intervention period. • Parents agreeing to initiate complementary feeding after finalization of the study (endpoint measurements at ~5.5 months of age) • Being available for follow up until the age of approximately 5.5 months • Written informed consent
Exclusion criteria
Exclusion criteria: • Gestational age 90th centile • Age at enrolment: >2 months/55 days and <2.5 months / 80 days • Severe acquired or congenital diseases, mental or physical disorders including cow’s milk protein allergy, lactose intolerance and diagnosed medical conditions that are known to affect growth (i.e. GI disorders) • Illness at screening/inclusion • Incapability of parents to comply with the study protocol • Participation in another clinical trial • Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth, measured as weight gain in g/day | — |
Secondary
| Measure | Time frame |
|---|---|
| Anthropometry, including - Weight (kg) - Recumbent length (cm and cm/day) - Head circumference (cm and cm/day) - BMI - Weight-for-length - Z-scores for all the above | — |
Outcome results
None listed