The Intestinal Innate Immune System in Newborns. Development and Inflammation in
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- If faecal IgA may be an early marker of NEC in preterm infants
研究概览
简要总结
The goal of this observational study is to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life. The main questions aim to answer are:
- to determine the normal development of the human intestinal immune system in premature and mature neonatal life and to determine the pathophysiology behind life-threatening gastrointestinal diseases that appear during early life.
- is to investigate the development of the immune system in relation to enteral nutrition during the neonatal period.
Participants will be asked to give faecal samples from day 1 of life and weekly for the following weeks until discharge (preterm infants). Further, surgery faecal samples and intestinal tissue will be collected proximal and distal to the pathology. In cases with a stoma, and when the child will undergo later reversal surgery, tissue samples from the proximal and distal ends of the intestine will be collected together with fecal samples (preterm and children up to 1 year of age who need to undergo intestinal surgery due to atresia).
详细描述
- NEC Study 1.1. Inclusion criteria Premature infants born < GA week 32. The total number to be included will be 200 1.2. Exclusion criteria Premature born with congenital diseases or other serious conditions may defer participation.
Situations where collection of tissue at surgery is impossible or problematic e.g. due to the remaining length of the vital intestine are evaluated to be too short according to the discretion of the operating surgeon.
1.3. Study design Infants will be included just after birth after obtaining consent based on written and verbal information. Faecal samples will be collected from day 1 of life and weekly for the following weeks until discharge to investigate the composition of the faecal microbiome in relation to the development of NEC and the effect of medical therapy.
In case of the development of NEC with the need for surgery, the affected intestine will be resected, and stomas will be established. Samples of faecal content and tissue are collected from the intestine proximal and distal to the divided intestine. At the time of reversal of stomas, the tissue will be collected both proximal and distal from division to investigate the development of the intestine during early life as well as potential nutritional effects on intestinal maturity. Infants who do not undergo surgery serve as controls, those who are treated for NEC with antibiotics only, will be included in a sub-analysis comparing the microbiome of infants who need surgery.
1.4. Sampling 1.4.1. Fecal samples Faecal samples are collected as soon as possible after birth and once weekly until discharge. Faeces is scraped off the diaper as soon as this appears. The amount must match a fingernail. Two samples are collected at each time point. Faces will be stored in an appropriate tube, after collection, the content is mixed with a buffer (saline) 1:2 before freezing at -600 degrees C. Fecal content collected at primary surgery and at stoma reversal, samples are prepared similarly.
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 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature infants born < GA week 32 Atresia study
- •All newborn and children up to 1 year of age who needs to undergo intestinal surgery due to atresia at any site of the intestine.
排除标准
- •NEC study - Premature born with congenital diseases or other serious conditions which may defer participation. Situations where collection of tissue at surgery is impossible or problematic e.g. due to remaining length of vital intestine is evaluated to be too short according to the discretion of the operating surgeon.
- •Atresia study
- •Infants and children where intestinal tissue sampling would compromise surgery and the health of the patient subsequent.
结局指标
主要结局
If faecal IgA may be an early marker of NEC in preterm infants
时间窗: 6 years
IgA measures in repetative faecal samples from admission till disease or GA 34 weeks in no-NEC infants
Development of the intestinal immune system over time
时间窗: 6 years
mRNA sequencing of intestinal tissue from preterm infants exposed to surgery due to NEC and compared to intestinal tissue removed from term infants undergoing surgery due to atresia.
次要结局
- Nutritional impact on intestinal development(6 years)
- Bowel habits in preterm infants as marker for later intestinal disease(6 years)
研究者
Lise Aunsholt
senior consultant, Ph.D., Associate Professor
Rigshospitalet, Denmark