Clinical trial NCT06475521: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 579
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, controlled, double-blinded, multi-country, multi-center

Including Breastfed reference group
Primary purpose: BASIC_SCIENCE

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.

Detailed description: The study will include infants to be randomised to receive the Test or Control product for 52, and infants whose parents have the intention to provide exclusively breastfeeding for at least 16 weeks after enrolment. Baseline assessments will be done at Visit 1/enrolment visits.

Subjects will return for clinic visits at 2 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6) 26 (Visit 7), 39 (Visit 8), and 52 (Visit 9) weeks post-baseline. During these clinic visits the investigator will perform anthropometric measurements, interview parent(s) about their infant's product intake/breastfeeding, occurrence of (serious) adverse events, medication/nutritional supplement use, details of infections and antibiotic/antiviral usage (if applicable).

At selected visits the following will be assessed a) stool characteristics (V2, 4, 6, 7,8, 9)); b) type of weaning food introduction (as of V6); c) neurocognitive development (V9); d) a three-day 24 hour food recall for dietary intake; e) stool samples at (V1, 6, 9); and f) blood sample (V6).

Also, a follow-up phone call is planned 2 weeks after the last visit.

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.

Primary outcomes:
measure: Weight gain
timeFrame: Baseline to 16 weeks post-baseline
Secondary outcomes:
measure: Neurocognitive Development
timeFrame: 52 weeks post baseline
Other outcomes:
Locations:
city: Dupnitsa
country: Bulgaria
facility: Medical Centre Asklepiy OOD Dupinista
Study officials:
References: