Growth
Conditions
Brief summary
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, until the age of 17 weeks.
Detailed description
In this clinical trial, weight gain (primary objective), and additional anthropometry (secondary objectives), of infants exclusively consuming a hydrolysed protein-based infant formula were evaluated and compared to a standard intact protein-based formula over a period of at least three months, at the age of 8, 13, and 17 weeks. 345 healthy term infants, exclusively formula-fed were included.
Interventions
OTHERinfant formula based on hydrolyzed protein
infant formula based on hydrolysed protein
OTHERinfant formula based on intact protein
infant formula based on intact protein
Sponsors
FrieslandCampina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Days to 28 Days
Healthy volunteers
Yes
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
* Gestational age \<37 weeks * Birth weight \<2500 g or \>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 | Description |
|---|---|---|
| weight gain | until 17 weeks of age | weight gain in g/day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | until 17 weeks of age | Weight in g |
| Length | until 17 weeks of age | length in cm |
| head circumference | until 17 weeks of age | head circumference in cm |
| BMI | until 17 weeks of age | BMI in kg/m2 |
| LAZ | until 17 weeks of age | length-for-age Z-score |
| WHZ | until 17 weeks of age | weight-for-height Z-score |
| BMI-for-age Z-score | until 17 weeks of age | BMI-for-age Z-score |
| head circumference-for-age Z-score | until 17 weeks of age | head circumference-for-age Z-score |
| WAZ | until 17 weeks of age | weight-for-age Z-score |
Other
| Measure | Time frame | Description |
|---|---|---|
| formula intake | until 17 weeks of age | formula intake in ml |
Countries
Greece
Outcome results
None listed