Идёт набор NCT05868408

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

Без фазы С лечением Infant Nutritional Physiological Phenomena Infant Formula Infant Health Infant Development

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Control Formula, Experimental Formula 1, Experimental Formula 2.
Кому может быть актуально: Состояния в реестре: Infant Nutritional Physiological Phenomena, Infant Formula, Infant Health, Infant Development. Базовые параметры: 0 Days — 28 Days · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Филиппины, Саудовская Аравия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial

Обзор

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Вмешательства

Другое Control Formula
Infant formula made with intact protein - minimum 1.8g protein/100kcal
Другое Experimental Formula 1
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
Другое Experimental Formula 2
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

Первичные конечные точки

Difference in growth in first 4 months of life between control and experimental groups [Срок оценки: From enrollment to age 4 months]
Equivalence in growth in first 4 months of life in experimental groups [Срок оценки: From enrollment to age 4 months]

Вторичные конечные точки (12)

Gastrointestinal (GI) tolerance [Срок оценки: Enrollment and age 4, 6, and 12 months]
Stooling pattern [Срок оценки: Age 2 and 4 months]
Atopic dermatitis severity [Срок оценки: Enrollment and age 4, 6, and 12 months]
Allergy-related symptoms [Срок оценки: Enrollment and age 4, 6, and 12 months]
Dietary intake [Срок оценки: Age 6 months]
Weight [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]
Length [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]
Head circumference [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]
Weight-for-age z-score [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]
Weight-for-length z-score [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]
Length-for-age z-score [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]
Head circumference-for-age z-score [Срок оценки: Enrollment and age 1, 2, 3, 4, and 6 months]

Критерии участия

Критерии включения

Written informed consent has been obtained from at least one parent (or other legally acceptable representative \[LAR\]), if applicable)
Infant gestational age ≥37 completed weeks
Infant birth weight of ≥2.5 kg and ≤4.5 kg
Singleton birth
For Saudi: Infant postnatal age ≤28 days (date of birth = day 0); For Philippines: Infant postnatal age ≥ 14 days and ≤ 28 days (date of birth = day 0).
Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk
Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol

Критерии исключения

Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)
Infants with special dietary needs other than standard infant formula
Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy, or lactose intolerance or severe food allergies that impact diet
Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study
Currently participating or having participated in another interventional clinical trial prior to enrollment

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

Здоровые добровольцы: Да