Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula

Обзор

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.

Вмешательства

• Другое Rice formula (New formula based on hydrolysed rice proteins)
  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)).
• Другое Control formula (Standard cow's milk proteins-based formula)
  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)).

Первичные конечные точки

• Daily weight gain [Срок оценки: From enrollment to the end of intervention at 120 days of age]

Критерии участия

Inclusion Criteria:Should be included healthy term infants:

• with a gestational age comprised between 37 and 42 weeks
• with an adequate weight for gestational age at birth (weight birth comprised between the 10th and 90th percentiles of French Audipog growth charts)
• aged between 7 and 13 days at time of enrolment
• from singleton pregnancies
• whose mothers, prior to inclusion in the study, had independently opted for exclusive formula feeding
• exclusively fed with infant formula for at least 5 days prior to enrolment
• whose both parents/legal representative(s) agreed to participate in the study by signing written informed consents
• whose at least one parent/legal representative is beneficiary of a social security scheme according to the local regulations.

Exclusion Criteria: Should not be included:

• infants with significant prenatal disease or anatomic or physiologic conditions or use of medications that would interfere with normal growth, development, or feeding
• infants with hospitalization within the first 2 weeks of life after leaving the maternity ward except for hyperbilirubinemia
• infants with suspected or diagnosed cow's milk allergy or any other known or suspected food intolerance/allergy (lactose, fish, soy …)
• infants with special dietary needs, feeding difficulties
• infants with antibiotic use before inclusion
• infants participating or having participated in another clinical trial since their birth.
• infants born to mothers with medical conditions that could interfere on the infant's gastrointestinal tract/ability to be fed and/or growth (e.g., eclampsia, insulin-dependent diabetes mellitus)
• infants whose mothers used illicit drugs or alcohol during their pregnancy
• infants whose parents cannot comply with the protocol requirements.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07686224 · RIGA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗