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 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•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
•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;
•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.

发起方

utricia Research