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.

NCT06475521 | Enrolling By Invitation

• 1 other identifier: SBB22R&56319
• Study Type: interventional
• Target: 579
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants

Outcome Measures

Primary Outcomes (1)

• Weight gain

  To demonstrate equivalence in mean weight gain per day from baseline to 16 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product

  Baseline to 16 weeks post-baseline

Secondary Outcomes (1)

• Neurocognitive Development

  52 weeks post baseline

Study Arms (2)

Arm 1

EXPERIMENTAL

Infant formula test group; Group that receives the test product.

Other: Infant Formula

Arm 2

ACTIVE COMPARATOR

Infant formula control group; Group that receives a comparative control product.

Other: Infant Formula

Interventions

Infant Formula OTHER

Test group

Arm 1; Arm 2

Eligibility Criteria

• Age: 0 Days - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nutricia Research: lead

Study Sites (2)

Medical Centre Asklepiy OOD Dupinista

Dupnitsa, 2600, Bulgaria

Location

Gyncentrum Spółka Z Ograniczoną Odpowiedzialnością,

Katowice, Lesser Poland Voivodeship, 40-851, Poland

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk Substitutes; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food, Formulated; Foods, Specialized; Food; Infant Food; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised, controlled, double-blinded, multi-country, multi-center Including Breastfed reference group

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 26, 2024
• Study Start: July 17, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1); PL (1)