| Eligibility |
Inclusion Criteria:
- 1. Healthy, singleton, term infants (gestational age =37 weeks + 0 days and =41weeks +
6 days);
2. Infants with age at screening =14 days;
3. Birth weight within 10th to 90th percentile per gestational age and sex, according
to Intergrowth Standards;
4. Head circumference at screening within ±2 SD per age and sex according to WHO Child
Growth Standards;
5. a Randomised groups: Infants who are exclusively formula fed and/or whose mothers
have autonomously decided to exclusively formula feed, i.e. not to breastfeed or have
ended breastfeeding before screening, and who are intending to exclusively formula
feed at least till their infant is 17 weeks of age; OR b Breastfed reference group:
Infants who are exclusively breastfed and whose mothers are intending to exclusively
breastfeed at least till their infant is 17 weeks of age;
6. Written informed consent from parent(s) and/or legal guardian(s) aged =18 years at
screening.
Exclusion Criteria:
- 1. Randomised groups: Infants who require a special diet other than non-hydrolysed,
cow's milk based infant formula (e.g. due to known or suspected to have cow's milk
allergy, soy allergy and/or lactose intolerance);
2. Infants with current or previous illnesses/conditions and/or known or suspected
congenital diseases or malformations which could interfere with the study or its
outcome parameters, such as but not limited to: GI malformations, congenital metabolic
disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as
per the clinical judgement of the Investigator;
3. Infants with previous, current or intended participation in any other clinical
study involving investigational or marketed products;
4. Incapability of infants' parents to comply with study protocol as per the judgement
of the Investigator;
5. Infants born from mothers known to have (any) hepatitis or human immunodeficiency
virus;
6. Infants born from mothers with significant medical conditions during pregnancy that
might interfere with the study or its outcome parameters or known to affect
intra-uterine growth (e.g. placenta previa, pre-eclampsia, eclampsia, Type 1, 2
diabetes) as per clinical judgement of the Investigator;
7. Infants born from mothers, who did participate in any clinical study involving
investigational products during pregnancy, and for infants in Breastfed reference
group: mothers who are currently participating or intend to participate in any
clinical study involving investigational products during lactation.
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