Dietary Modification
Conditions
Brief summary
The purpose of this study is to assess the growth of infants fed with BabyNes System, compared to the World Health Organization Reference, during the first four months of life.
Interventions
OTHERTest formula
Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy newborn * Full term newborn (≥ 37 weeks gestation) * Birth weight ≥ 2500 g and ≤ 4500 g * Newborn from birth to 14 days of age at the time of enrollment * The newborn's mother has voluntarily elected to exclusively formula feed her newborn * Having obtained his/her signed legal representative's informed consentHealthy newborn infant
Exclusion criteria
* Congenital illness or malformation that may affect normal growth (especially immunodeficiency) * Newborn whose mother's BMI was abnormal (\<18.5 or \>30kg/m2) at start of pregnancy * Newborn whose mother has diabetes of type-1 or type-2 * Newborn whose mother has a chronic infectious disease * Newborn whose parents / caregivers cannot be expected to comply with treatment * Newborn currently participating in another nutritional interventional clinical trial (except for vaccination studies)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| z-score weight-for-age (WHO Child Growth Standards) | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth | 12 months | BMI for age z-scores, weight for length z-scores, length for age z-scores, head circumference for age z-scores |
| Compliance | 12 months | Volume of formula intake |
| Morbidity | 12 months | Number of infants with adverse events |
Countries
Switzerland
Outcome results
None listed