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| Name | Class |
|---|---|
| Instituto de Nutricion y Tecnologia de los Alimentos (INTA) | UNKNOWN |
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This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational nutrient-rich whey protein formula | Experimental |
| |
| Cow's milk based formula | Active Comparator |
| |
| Breast milk | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational nutrient-rich whey protein formula | Other |
| ||
| Cow's milk based formula |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | 24 months | |
| Auditory Event-related Potential | 24 months | |
| Body length | 24 months | |
| Head circumference | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake | 24 months | |
| Medically confirmed adverse events | 24 months | |
| Body Composition: Air Displacement Plethysmography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carol Lynn Berseth, MD | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Nutricion y Tecnologia de los Alimentos | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32423392 | Derived | Toro-Campos R, Algarin C, Peirano P, Pena M, Murguia-Peniche T, Wu SS, Uauy R. Effect of feeding mode on infant growth and cognitive function: study protocol of the Chilean infant Nutrition randomized controlled Trial (ChiNuT). BMC Pediatr. 2020 May 18;20(1):225. doi: 10.1186/s12887-020-02087-9. |
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| Other |
|
| 6 months |
| Body Composition: Deuterium Dilution | 12 and 24 months |
| Blood sample: Micronutrient status | 24 months |
| Blood sample: Metabolic markers | 24 months |
| Bayley Scales of Infant and Toddler Development | 12 months |
| Sleep measures (Amount of time awake & asleep in a 7-day period) | 24 months |
| Language development: Native3 Phoneme Repertory | 12 months |
| Language development: Word Discovery | 10 months |
| Language development: Rule Inference | 10 months |
| Language development: MacArthur Communicative Development Inventory | 24 months |