Comparing a new infant formula to a control for healthy term infants
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.
This study is testing a new infant formula to see if it helps healthy babies grow and develop as well as a standard formula over a year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 579 (estimated) |
| Ages | 0 Days to 14 Days |
| Sex | All |
| Sponsor | Nutricia Research Industry-sponsored |
| Locations | 1 site (Dupnitsa) |
| Trial ID | NCT06475521 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the growth equivalence and neurocognitive development of a new infant formula compared to a control product over a period of 52 weeks. Infants will be randomly assigned to receive either the test formula or the control formula, with assessments conducted at multiple clinic visits to monitor growth, dietary intake, and developmental milestones. Additionally, a breastfed reference group will be included for comparison. The study will also gather data on anthropometric measurements and any adverse events throughout the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy, term infants aged 14 days or younger who are either fully formula-fed or exclusively breastfed.
Not a fit: Infants with special dietary needs, allergies to cow's milk, fish, or soy, or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for a new infant formula that supports healthy growth and neurocognitive development in infants.
How similar studies have performed: Other studies have shown success in evaluating infant formulas, but this specific approach may offer novel insights into neurocognitive development.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dupnitsa
- Medical Centre Asklepiy OOD Dupinista — Dupnitsa, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Danone Nutricia Research
- Email: register.clinicalresearchnutricia@danone.com
- Phone: 0302095000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.