New baby formula aims to boost brain power in infants
NCT ID NCT06475521
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a new infant formula helps healthy babies grow and develop their brains as well as standard formula or breast milk. About 579 healthy, full-term newborns will be fed either the new formula, a standard formula, or breast milk for up to 52 weeks. Researchers will measure weight gain and use a standard test of thinking and learning skills at one year of age.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- new infant formula
- What this could lead to
- If successful, this could show that the new formula supports normal growth and may improve early brain development in formula-fed babies.
- What could go wrong
- This is an early-stage study in healthy infants, so results may not apply to all babies. The brain development benefit is a secondary goal and may not be proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 579 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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0 to 14 days
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gyncentrum Spółka Z Ograniczoną Odpowiedzialnością,
Katowice, Lesser Poland Voivodeship, 40-851, Poland
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Medical Centre Asklepiy OOD Dupinista
Dupnitsa, 2600, Bulgaria