NCT02570698已完成不适用
Collection and Characterization of Premature Infants Feces for Identification of Factors Contributing to Skin Irritation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Composition of proteins (ug/uL) in premature infant feces
研究概览
简要总结
The primary objective of this study is to collect feces from premature infants over a five weeks period to characterize its composition. Metabolomics, Proteomics, Genomics and Microbiome analyses and cell-based assays will be performed to identify individual components present in feces, which may contribute to the onset of irritation in the diapered area of premature infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infant's parent(s)/legal guardian(s) must be fluent in English or Spanish, willing and able to read, understand, and sign the informed consent form (ICF).
- •Infants (male or female) who are equal or less than a gestational age of 30 weeks + 4 days.
排除标准
- •Any medical condition which, in the opinion of the principal investigator, may compromise infant's safety.
- •Any underlying chronic skin conditions. However, infants may participate in the study with a rash in the diapered area if, in the opinion of the principal investigator, this does not compromise infant's safety.
结局指标
主要结局
Composition of proteins (ug/uL) in premature infant feces
时间窗: 0 to 5 weeks
This is an observational study where fecal samples will be collected twice each week for 5 weeks from enrolled patients. Primary analysis will consist of identification and quantification proteins present in samples.
次要结局
未报告次要终点
研究者
研究点 (1)
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