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
- Conditions
- Growth, Weight gainWeight gain
- Registration Number
- NL-OMON45527
- Lead Sponsor
- utricia Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome parameter in this study is weight gain in grams per day<br /><br>from baseline until 17 weeks of age. </p><br>
- Secondary Outcome Measures
Name Time Method