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| Name | Class |
|---|---|
| Vivactis M2Research | INDUSTRY |
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The goal of this interventional clinical trial is to compare the growth parameters of healthy term infants fed either a new experimental rice hydrolyzed rice protein-based formula or a control formula (standard cow's milk protein-based formula), from their study enrollment until the age of 4 months (postnatal age of 120 days).
The main question it aims to answer is whether daily weight gain of infants fed the experimental formula during the first 4 months of life is non-inferior to that of infants fed the control formula.
Participants are fed exclusively with their assigned formula from enrollment until 120 days of postnatal age.
Parents record any deviation from exclusive feeding with the assigned formula (e.g., intake of solid foods, unauthorized beverages, or any other infant formula).
During the 3 days prior to each study visit (on postnatal days 20, 30, 60, 90, and 120):
They evaluate their child's quality of life at enrollment, and on postnatal days 60 and 120.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rice formula | Experimental | Hydrolyzed rice proteins-based formula |
|
| Control formula | Active Comparator | Standard cow's milk proteins-based infant formula |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rice formula (New formula based on hydrolysed rice proteins) | Other | The infant is exclusively fed the infant formula based on hydrolysed rice proteins from inclusion (postnatal age: day 10 (±3)) until the postnatal age of 4 months (day 120 (±3)). |
| Measure | Description | Time Frame |
|---|---|---|
| Daily weight gain | From enrollment to the end of intervention at 120 days of age |
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Inclusion Criteria:Should be included healthy term infants:
Exclusion Criteria: Should not be included:
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| Control formula (Standard cow's milk proteins-based formula) | Other | The infant is exclusively fed the control formula from inclusion (postnatal age: day 10 (±3)) until the postnatal age of 4 months (day 120 (±3)). |
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