NCT05717283已完成不适用
Follow-up of the Nasal Microbiome and Viral Infections in Newborns Hospitalised in Neonatology in the University Hospital of Caen, France : Metatranscriptomics Approach by Next Generation Sequencing From Nasal Swabs.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in microbiome abundance
研究概览
简要总结
The goal of this interventional study is to learn about nasal microbiome and viral infections in newborns hospitalised in neonatology.
The main questions it aims to answer are :
- how often are newborns infected by viruses in neonatology ?
- how does the microbiome develop during first weeks of life ?
- how does microbiome and viruses interacts together ?
- is there a link between viral infection, microbiome, and medical complications during hospitalisation in neonatology ? Participants will have a nasal swab taken each week during their hospitalisation in neonatology, and researchers will take medical data from the medical chart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newborn hospitalised in neonatal intensive care unit during the inclusion period
- •parents have been informed about the study (speaking french) and have signed the informed consent.
- •affiliated to the social security system.
排除标准
- •parental refusal
- •minor parents or under judicial protection
- •newborn who already have been discharded home before inclusion
- •hospitalisation after the first 48 hours of life
- •only palliative care
结局指标
主要结局
Change in microbiome abundance
时间窗: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Number of reads for a given taxonomy.
Change in microbiome diversity
时间窗: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Shannon diversity index
Virus presence
时间窗: Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).
Molecular detection of respiratory viruses using multiplex PCR.
次要结局
- Occurence of bronchopulmonary dysplasia(At discharge from neonatology.)
- Change in expression of local innate immunity markers(Day 0, day 7, day 14, and each week until discharge (maximum duration : 3 months for each newborn).)
研究者
研究点 (1)
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