growth, weight gain, anthropometry, gastrointestinal comfort, safety, suitability, hydrolysate, intact protein, infant formula
Conditions
Sponsors
FrieslandCampina
Eligibility
Inclusion criteria
Inclusion criteria: • Full-term infants (born at gestational age =37 weeks). • Healthy birthweight (according to WHO Child Growth Standards): between 2500 and 4200 g, retrieved from medical records • Boys and girls • Apparently healthy at birth and screening • Weight-for-age Z-score (WAZ), weight-for-length (WHZ), and length-for-age (LAZ) Z-scores at screening within the normal range according to WHO Child Growth Standards (i.e. -2 = WAZ,WHZ,LAZ = 2) • Age at enrolment: =28 days of age • Exclusively formula fed for at least 5 days prior to inclusion • Exclusively formula fed during the entire intervention period • Parents agreeing to initiate complementary feeding after finalization of the study • Being available for follow up until the age of approximately 3.5 months • Written informed consent from parent(s) and/or legal guardian(s) aged =18 years
Exclusion criteria
Exclusion criteria: • Gestational age 4200 g • Age at enrolment: >28 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 • Illiterate parents (i.e. not able to read and write in local language) • Participation in another clinical trial • Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation • infants fed a special diet other than standard, non-hydrolysed, cow’s or goat’s milk based infant formula
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 - Z-scores for all the above | — |
Contacts
Public ContactJeske Hageman
FrieslandCampina
Outcome results
None listed