A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and H… (NCT06475521) | Clinical Trial Compass
By InvitationNot Applicable
A Randomised, Controlled, Double-blinded, Multi-country, Multi-centre Trial to Study Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
To demonstrate growth equivalence of a Baby formula Test Product when compared to the Control product after 16 weeks. And to demonstrate better neurocognitive development at 52 weeks post-baseline in subjects receiving the Test Product, compared to subjects receiving the Control Product. Also, other anthropometric parameters will be investigated up to 52 weeks.
A Breastfed reference group, exclusively breastfed for at least 16 weeks, will also be included.
Who can participate
Age range0 Days – 14 Days
SexALL
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Inclusion Criteria:
* Healthy, singleton, term born infants (gestational age ≥ 37 weeks + 0 days and ≤ 41 weeks + 6 days).
* Infants aged ≤ 14 days at enrolment.
* Weight at birth within 10th to 90th percentile per gestational age and sex, according to Intergrowth Standards
* For formula feeding groups: Infants fully formula fed at the time of enrolment.
* For breastfed reference group: Infants exclusively breastfed at the time of enrolment and parent(s) intend to exclusively breastfeed the infant at least until 16 weeks after Visit 1.
* Written informed consent (IC) from parent(s) and/or legally acceptable representative(s) aged ≥18 years at enrolment.
Exclusion Criteria:
* . Infants who require a special diet other than IF with intact cow's milk protein.
* Infants known or suspected to have cow's milk, fish, and/or soy allergy and/or lactose intolerance.
* Infants with current or previous illnesses/conditions and/or known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.
* Infants whose mother is known to suffer from an illness or condition which could interfere with the study outcomes, as per investigator's clinical judgement.
* Infants with previous, current, or intended participation in any concomitant clinical study involving investigational or marketed products.
* Investigator's uncertainty about the willingness or ability of parents or legally acceptable representative(s) to co…