Gastrointestinal Tolerability of a Partially Hydrolyzed, Whey-based, Ready-to-feed Infant Formula in Healthy Newborns During the Birth Hospitalization Period: a Post-market Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Parent-reported individual GI- and feeding-related behaviors
研究概览
简要总结
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent has been obtained from both parents or a legally acceptable representative (LAR).
- •Full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2500 g and ≤ 4500 g.
- •Parent(s) must have independently elected, before enrollment, to formula feed.
- •Infant age ≤ 24 hours after birth.
- •Child's parents / LAR are of legal age of consent, must understand the informed consent form and other study documents, and are willing and able to fulfill the requirements of the study protocol.
排除标准
- •Infant is exclusively breastfed.
- •Evidence of significant cardiac, respiratory, endocrine, hematologic, gastrointestinal, or other systemic diseases, infections, or disorders.
- •Infant has other condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
- •Conditions that require infant feedings other than those specified in the protocol.
- •Infant is currently participating in another interventional clinical trial that impacts study outcomes.
结局指标
主要结局
Parent-reported individual GI- and feeding-related behaviors
时间窗: At study completion (age 2 to 5 days)
At discharge, parents will complete the Gastrointestinal Tract Function sub-scale of the NeoEAT questionnaire (either the Bottle-Feeding or the Mixed-Feeding version, depending on the mother's chosen feeding mode) to document GI- and feeding-related behaviors using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort and problematic feeding behavior.
Number of infants with specific GI characteristics
时间窗: Daily through study completion (age 2 to 5 days)
GI symptoms and GI-related behaviors, as documented by health care providers in the infants' hospital medical charts (e.g., diarrhea, constipation, and vomiting)
Number of feeds per day
时间窗: Daily through study completion (age 2 to 5 days)
Number of formula feeds per day, number of breastfeeds per day (if mixed fed), as documented by health care providers in the infants' hospital medical charts
Parent-reported individual gastrointestinal (GI) symptoms and GI-related behaviors
时间窗: Daily through study completion (age 2 to 5 days)
The Newborn Infant GI Tolerance eDiary will be completed daily (preferably in the evening) by parents, who will document the frequency and severity of diarrhea, gassiness, spitting-up, vomiting, reflux, abdominal pain, fussiness, crying, and sleep patterns using a 6-point scale (from Never to Always). Higher scores indicate more symptoms of GI discomfort.
次要结局
未报告次要终点