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Active Not Recruiting NCT06475521

Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.

Conditions: Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants

Sex: All
Ages: 0 Days – 14 Days
Healthy volunteers: Yes
Phase: NA
Enrollment: 579
Sponsor: Nutricia Research

Location: Medical Centre Asklepiy OOD Dupinista Dupnitsa

Summary

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.

Eligibility Criteria

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 comply with the protocol requirements.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06475521). StuddyBuddy aggregates publicly available trial information.