Influence of Intestinal Microbiota Implantation Parameters in the Neonatal Period in Premature Infants on Microbiota Profiles and Immune Orientation at 3 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 6
- 主要终点
- The presence/absence of a Th1 type immune orientation
研究概览
简要总结
The main objective of this research is to study the links between changes in the intestinal microbiota (in terms of diversity) during the first 6 weeks of life for preterm infants and the presence / absence of a TH1 immune status at 36 months of age.
详细描述
The secondary objectives are to study the links between changes of the intestinal microbiota premature infants in terms of:
- changing diversity of the microbiota in the first 6 weeks of life;
- changes in the bacterial community (UniFrac study) during the first 6 weeks of life;
- diversity of the microbiota up to 6 weeks;
-AND-
- diversity of the microbiota at 1, 2 & 3 years;
- bacterial communities (UniFrac study) at 1, 2 & 3 years;
- lymphocyte subpopulation profiles at 3 years;
- serum immunoglobulin A, G, M, E levels at 3 years;
- history of infectious episodes, allergic and inflammatory episodes during the first 3 years of life.
The links between certain variables known in the literature and neonatal microbiota will be confirmed / studied in our population:
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 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The parents of the patient (or legal guardian if any) have been informed about the implementation of the study, its objectives, its constraints, and patient rights
- •The parents of the patient (or legal guardian if any) must have given their free and informed consent and signed the consent form
- •The patient must be affiliated with or beneficiary of a health insurance plan
- •Premature infants born at less than 33 weeks of gestation
排除标准
- •The patient is participating in another interventional study (Excepted " Recherche du Portage de Clostridium butyricum et de Toxines de Clostridium chez les Prématurés Hospitalisés en Néonatologie afin de prédire la survenue d'Entérocolites Nécrosantes", RCB 2016-A00-529-42 ; " BetaDose Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth ", RCB 2016-001486-
- •It is not possible to correctly inform the parent (or legal guardian, if applicable)
- •A serious deformity or digestive malformation was diagnosed at birth
- •During the hospital stay in the neonatology department, the patient had a digestive disease requiring surgery (except necrotizing enterocolitis)
- •A transfer to another hospital is foreseen/predictable (eg, due to geographical distance)
研究组 & 干预措施
The study population
The study population corresponds to infants born at less than 33 weeks of gestation.
结局指标
主要结局
The presence/absence of a Th1 type immune orientation
时间窗: 36 months
Immune orientation will be determined according to the following ratio determined by lymphocyte stimulation tests: INF-gamma/(INF-gamma+IL+4). The latter ratio varies between 0 and 0.5 with IL-4 \> INF-gamma (TH2 orientation) and between 0.5 and 1 when INF-gamma \> IL-4 (TH1 orientation).
次要结局
- Blood lymphocyte subset determination(36 months)