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 record all baby bottles consumed by their children * They assess their child's digestive tolerance of the formula, behavioral parameters, and acceptance of the formula. They evaluate their child's quality of life at enrollment, and on postnatal days 60 and 120.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
156
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)).
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)).
Private practice - Dr. Chevé
Brest, France
NOT_YET_RECRUITINGPrivate practice - Dr. Brancato
Brignon, France
NOT_YET_RECRUITINGPrivate practice - Dr. Delobbe
Brumath, France
NOT_YET_RECRUITINGPrivate practice - Dr. Béguin
Charly, France
RECRUITINGPrivate practice - Dr. Houeto
Hyères, France
RECRUITINGPrivate practice - Dr. Blasquez
Libourne, France
NOT_YET_RECRUITINGPrivate practice - Dr. Dumont
Marseille, France
RECRUITINGPrivate practice - Dr. Achkar-Helou
Senlis, France
RECRUITINGPrivate practice - Dr. Gembara
Vichy, France
NOT_YET_RECRUITINGDaily weight gain
Time frame: From enrollment to the end of intervention at 120 days of age
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