NCT05047978已完成不适用
Growth and Tolerance of a Partially Hydrolyzed Cow's Milk Protein (PHP) Infant Formula
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 13
- 主要终点
- Rate of body weight gain
研究概览
简要总结
The purpose of this research study is to compare the growth and tolerance of infants who consume either an infant formula with intact proteins or an infant formula with partially hydrolyzed proteins through approximately 12 months of age.
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
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •10 to 14 days of age at randomization
- •singleton birth
- •Gestational age of 37 to 42 weeks
- •Birth weight of 2500 g (5lbs 8oz or more)
- •Exclusively receiving infant formula for at least 24 hours prior to randomization
- •Parent or legal guardian has full intention to exclusively feed study formula through 120 days of age
- •Parent or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- •Signed informed consent and authorization to use and disclose Protected Health information
排除标准
- •History of underlying metabolic or chronic disease
- •Evidence of feeding difficulties or history of formula intolerance
- •Weight at Visit 1 is <98% of birth weight
- •Infant was born large for gestational age from a mother who was diabetic at childbirth
- •Infant is immunocompromised
研究组 & 干预措施
A routine cow's milk-based infant formula
Active Comparator
A routine cow's milk-based infant formula
干预措施: Cow's milk protein infant formula (Other)
A partially hydrolyzed cow's milk protein (PHP) infant formula
Experimental
A partially hydrolyzed cow's milk protein (PHP) infant formula
干预措施: Partially hydrolyzed protein infant formula (Other)
结局指标
主要结局
Rate of body weight gain
时间窗: up to 120 days
次要结局
- Growth Z scores(up to 365 days of age)
- Head circumference(up to 365 days of age)
- Recall of study formula intake measured at each study visit(up to 365 days of age)
- Pediatric Quality of Life Family Impact Module(up to 365 days of age)
- Body weight(up to 365 days of age)
- Body length(up to 365 days of age)
- Recall of stool characteristics measured at each study visit(up to 365 days of age)
- Specific medically confirmed adverse events related to gastrointestinal(up to 365 days of age)
- Specific medically confirmed adverse events related to allergy(up to 365 days of age)
- Pediatric Quality of Life Inventory Infant Scales(120, 180, 275, and 365 days of age)
- Medically confirmed adverse events collected throughout the study period(up to 365 days of age)
研究者
研究点 (13)
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