PremaBiom: Metatranscriptomics of the Respiratory Microbiome to Predict the Occurrence of Bronchopulmonary Dysplasia in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 试验地点
- 6
- 主要终点
- Diagnosis of bronchopulmonary dysplasia
研究概览
简要总结
The goal of this clinical trial is to understand the impact of respiratory microbiome maturation in respiratory health of preterm infants under 32 gestational weeks. The main questions it aims to answer are:
- What is the role of microbiome maturation in respiratory health (development of bronchopulmonary dysplasia, childhood asthma and viral respiratory infections) of preterm infants ?
- Which environmental or health factors are involved in the maturation of the respiratory microbiome ?
Participants will undergo follow-up from birth until 3 years of corrected age including nasal swabs, stool samples, and for some of them blood and milk sample.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational age at birth lower than 32 gestational weeks and 6 days.
- •Hospital stay in one of the participant neonatal care units
- •Infants covered by the social security system of at least one of their parents
- •Whose parents have been informed about the study and agree to sign the informed consent form
排除标准
- •Palliative care only
- •Lack of parental consent
- •Parents who are minors or under legal protection (guardianship, conservatorship, judicial protection)
- •Parents who do not speak French
研究组 & 干预措施
Observational arm
This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).
干预措施: Nasal swab (Biological)
Observational arm
This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).
干预措施: blood sampling (Biological)
Observational arm
This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).
干预措施: Mother milk sampling (Biological)
Observational arm
This is a cohort of preterm infants, the interventions provided additionally to standard care are biological sampling (nasal swab, stool, blood and milk).
干预措施: Stool sampling (Biological)
结局指标
主要结局
Diagnosis of bronchopulmonary dysplasia
时间窗: 36 gestational weeks
At 36 gestational weeks, bronchopulmonary dysplasia (BPD) will be retained if any ventilatory support (invasive, non invasive, high or low flow oxygen) is required at least 23h over 24. This definition is based on the Jobe 2001 criteria for BPD diagnosis moderate or severe.
次要结局
- Multidimensional analysis of microbiome profiles(At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.)
- Bronchopulmonary dysplasia severity(36 gestational weeks)
- Viral detection(At birth, 32 GW (gestational weeks), 36 GW and 4 months of corrected age.)
- Viral infections or bronchiolitis during childhood(1, 2, 4, 8, 12, 18, 24 and 36 months of corrected age.)
- Preschool asthma(Up to 36 months of corrected age.)
- Cellular RNA expression in peripherical blood(36 gestational weeks)