NCT03991949已完成不适用
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula With Prebiotic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 14
- 主要终点
- Weight
研究概览
简要总结
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 34 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Gestational age at birth less than 37 weeks
- •Birth weight less than 3200 g (approximately 7 pounds)
- •Postmenstrual age is 34 0/7 through 41 0/7 weeks at enrollment
- •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- •The currently-fed formula is a milk-based infant formula at a caloric density of ≤ 24 Cal/fl oz.
- •Singleton, twin, or triplet births only.
- •Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
- •Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Participant is taking and plans to continue taking medications, home remedies, herbal preparations, prebiotics or probiotics, rehydration solutions, or parenteral nutrition
- •Participant is known to require elective surgery with hospitalization, other than uncomplicated outpatient surgery, during the course of the study.
- •Participant is in another study that has not been approved as a concomitant study
- •Participant has an allergy or intolerance to any ingredient in the study product
- •Participant is currently receiving oxygen therapy
- •Participant is currently receiving antibiotics
- •Participant is currently receiving tube feedings
结局指标
主要结局
Weight
时间窗: SDAY 1 to SDAY 56
Change in weight-for-age z-score
次要结局
- Formula Intake(SDAY 1 to SDAY 56)
- Length(SDAY 1 to SDAY 56)
- Head Circumference(SDAY 1 to SDAY 56)
- Stool Characteristics(Study Day (SDAY) 1 to SDAY 56)
研究者
研究点 (14)
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