Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 8
- 主要终点
- Difference in growth in first 4 months of life between control and experimental groups
研究概览
简要总结
This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental formula 1
EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal
干预措施: Experimental Formula 1 (Other)
Experimental formula 2
EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base
干预措施: Experimental Formula 2 (Other)
Control formula
CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal
干预措施: Control Formula (Other)
结局指标
主要结局
Difference in growth in first 4 months of life between control and experimental groups
时间窗: From enrollment to age 4 months
To demonstrate that growth from enrollment to age 4 months of infants fed experimental formula 1 (EXPL1) or experimental formula 2 (EXPL2) is non-inferior to that of infants fed control formula (CTRL). This is measured by weight gain velocity (g/day).
Equivalence in growth in first 4 months of life in experimental groups
时间窗: From enrollment to age 4 months
To demonstrate that growth from enrollment to age 4 months is equivalent between infants fed EXPL1 or EXPL2. This is measured by weight gain velocity (g/day).
次要结局
- Atopic dermatitis severity(Enrollment and age 4, 6, and 12 months)
- Weight(Enrollment and age 1, 2, 3, 4, and 6 months)
- Dietary intake(Age 6 months)
- Stooling pattern(Age 2 and 4 months)
- Head circumference-for-age z-score(Enrollment and age 1, 2, 3, 4, and 6 months)
- Gastrointestinal (GI) tolerance(Enrollment and age 4, 6, and 12 months)
- Head circumference(Enrollment and age 1, 2, 3, 4, and 6 months)
- Allergy-related symptoms(Enrollment and age 4, 6, and 12 months)
- Length(Enrollment and age 1, 2, 3, 4, and 6 months)
- Weight-for-age z-score(Enrollment and age 1, 2, 3, 4, and 6 months)
- Weight-for-length z-score(Enrollment and age 1, 2, 3, 4, and 6 months)
- Length-for-age z-score(Enrollment and age 1, 2, 3, 4, and 6 months)