Growth, Weight gain Weight gain
Conditions
Interventions
After parent(s)/legal guardian(s) have agreed to and signed informed consent,
infants may enrol in the study. Infants, whose mother has the intention to
breastfeed her infant until the infants* age
growth
healthy infants
infant formula
weight gain
Sponsors
Nutricia Research
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: 1. Healthy term infants (gestational age * 37 weeks + 0 days and * 41 weeks + 6 days); 2. Infants* age at enrolment * 14 days; 3. Birth weight within normal range for gestational age and sex (10th to 90th percentile according to the WHO Child Growth Standards * or local growth standards if available); 4. Head circumference at inclusion within normal range for age and sex (within 2 SD curves according to WHO Child Growth Standards * or local growth standards if available); 5. Infant formula arms: infants who are exclusively formula fed by time of randomisation with a maximum infants* age of 14 days (infants of mothers who choose not to breastfeed or mothers who cease breastfeeding for any reason before the infant is 14 days of age); OR Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are intending to exclusively breastfeed their infant at least until the infant is 17 weeks of age; 6. Written informed consent from parent(s) and/or legal guardian(s) aged * 18 years.
Exclusion criteria
Exclusion criteria: Infants of pregnant women/mothers: 1. who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation; 2. known to have a significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator*s clinical judgement; Infants of parents: 3. who are incapable to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements; Infants: 4. who have to be fed with a special diet other than standard (non-hydrolysed) cow*s milk based infant formula 5. known to have current or previous illnesses/conditions which could interfere with the study or its outcome parameters, such as gastrointestinal malformations, congenital metabolic disorders, immune deficiency or major surgery, as per investigator*s clinical judgement; 6. with any history of, or current participation in any other study involving investigational or marketed products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameter in this study is weight gain in grams per day from baseline until 17 weeks of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gain from baseline until 17 weeks of age of * Recumbent length (mm/day) * Head circumference (mm/day) * Mid-upper arm circumference (mm/day) Z-scores of anthropometric parameters at 17 weeks of age: * Weight-for-age * Weight-for-length * Length-for-age * Body Mass Index (BMI)-for-age * Head circumference-for-age * Mid-upper arm circumference-for-age as of 13 weeks of age Blood parameters assessed at 17 weeks of age: * Albumin * Serum mineral markers: calcium, phosphorus, iron and magnesium * Blood Urea Nitrogen These parameters will only be measured in blood of infants, whose parents gave additional consent to draw blood. Safety parameters from baseline until 17 weeks of age as measured by: * Number, type and severity of (Serious) Adverse events and possible relatedness to study product * Use of (co-)medication Gastrointestinal tolerance parameters from baseline until 17 weeks of age including: * Occurrence and severity of gastrointestinal symptoms: - regurgitation (return of the milk into the mouth without force) - vomiting (return of the milk into the mouth with force) * Stool frequency * Stool consistency * Occurrence of diarrhoea * Occurrence of constipation | — |
Countries
The Netherlands
Outcome results
None listed