NL-OMON53046已完成不适用
ong-term monitoring of children with intestinal failure - Intestinal failure in children - Trompet study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0 至 17（—）
入选标准
- •Children, newly diagnosed with intestinal failure in the Erasmus MC-Sophia
- •Children*s Hospital. Three groups of children will be included:
- •1. Children with congenital gastro-intestinal anomalies with involvement of the
- •small intestine, independent of expected use of parenteral nutrition.
- •2. Neonates with an expected use of parenteral nutrition >= 1 week after a
- •gastrointestinal intervention (laparotomy).
- •3. Children with a (suspected) motility disorder or intrinsic disorder of the
- •intestinal mucosa (enteropathy) with an expected use of parenteral nutrition >
- •2 weeks and children with an expected use of parenteral nutrition >= 1 week
- •after a gastrointestinal intervention (laparotomy) after the neonatal period.
- •In addition, all children already known with intestinal failure and dependent
- •on home parenteral nutrition are eligible for this study (attending the
- •intestinal failure team at the Sophia Children's Hospital and Emma Children's
- •Next to this, healthy children will be asked for the collection of stool
- •samples (children of colleagues).
- •Furthermore, children known with intestinal failure, but not dependent on home
- •parenteral nutrition anymore (attending the intestinal failure team at the
- •Sophia Children's Hospital) will be asked for the collection of stool samples.
- •Also, parents of healthy infants will be asked for the collection of stool
- •samples as comparison for the newly diagnosed infants with potential intestinal
- •failure. In addition to this, infants undergoing inguinal hernia repair (who
- •are often born preterm) will be asked for collection of stool samples, also as
- •comparison.
排除标准
- •A (potential) subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Participating in an intervention study, interfering with primary outcome of
- •- Absence of written informed consent
- •- Insufficient knowledge of the Dutch language of the parents/caregivers and
- •participants (if older than 12 years)
研究者
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