NL-OMON45527
Completed
Phase 2
A randomised, controlled, double-blind, parallel group, multi-country study to investigate the effects of an infant formula containing partially hydrolysed proteins on growth, safety, and tolerance in healthy term infants - TENUTO
utricia Research0 sites12 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Growth, Weight gain
- Sponsor
- utricia Research
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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);
- •Breastfeeding reference arm: infants who are exclusively breastfed and whose mothers are
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;
Outcomes
Primary Outcomes
Not specified
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