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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Infant formula test group; Group that receives the test product. |
|
| Arm 2 | Active Comparator | Infant formula control group; Group that receives a comparative control product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infant Formula | Other | Test group |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neurocognitive Development | Demonstrate better neurocognitive development as measured by the Bayley Scales of Infant and Toddler Development (Bayley-3) cognitive composite score at 52 weeks post-baseline in subjects receiving the Test product, compared to subjects receiving the Control product. | 52 weeks post baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre Asklepiy OOD Dupinista | Dupnitsa | 2600 | Bulgaria | |||
| Gyncentrum Spółka Z Ograniczoną Odpowiedzialnością, |
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Randomised, controlled, double-blinded, multi-country, multi-center
Including Breastfed reference group
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| Katowice |
| Lesser Poland Voivodeship |
| 40-851 |
| Poland |
| ID | Term |
|---|---|
| D041943 | Infant Formula |
| ID | Term |
|---|---|
| D041941 | Milk Substitutes |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D005526 | Food, Formulated |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D007225 | Infant Food |
| D019602 | Food and Beverages |
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