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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.
Sponsor: Nutricia Research
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.
Key Details
Gender
All
Age Range
0 Days - 14 Days
Study Type
INTERVENTIONAL
Enrollment
579
Start Date
2024-07-17
Completion Date
2027-12-31
Last Updated
2026-03-23
Healthy Volunteers
Yes
Interventions
Infant Formula
Test group
Locations (2)
Medical Centre Asklepiy OOD Dupinista
Dupnitsa, Bulgaria
Gyncentrum Spółka Z Ograniczoną Odpowiedzialnością,
Katowice, Lesser Poland Voivodeship, Poland