NL-OMON56093尚未招募不适用
A randomized multicenter open-label controlled trial to show that mucous fistula refeeding reduces the time from enterostomy closure to full enteral feeds (MUCous FIstula REfeeding (*MUC-FIRE*) trial) - MUC-FIRE
niversity of Leipzig, Department of Pediatric Surgery0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 1（—）
入选标准
- •1. Only infants younger than 366 days of age with status post ileostomy or
- •jejunostomy creation (double loop enterostomies and split enterostomies (with
- •mucous fistula)) will be included in the study to create a homogenous cohort of
- •patients with similar diseases (e.g. necrotizing enterocolitis [NEC], focal
- •intestinal perforation [FIP]). Also, infants of this age group are unique in
- •several respects such as the response to parenteral nutrition and its hepatic
- •toxicity resulting into neonatal cholestasis. The ostomy localization is
- •restricted to the jejunum and ileum. Therefore, the cohort of
- •patients shows a similar bowel length for fluid-, vitamin- and electrolyte
- •resorption.
- •2. All patients with meconium ileus are included into the study. If later
- •(required) diagnostics verify cystic fibrosis, the diagnostics as well as the
- •diagnosis need to be documented in the eCRF and in further analysis subgroups
- •will be established.
- •3. Signed written informed consent obtained by parents/legal guardians and
- •willingness
- •of parents/legal guardians to comply with treatment and follow-up procedures of
排除标准
- •1. The resection of the ileocecal valve is an exclusion criterion because of
- •its association
- •with extensive bowel resection and therefore prolonged parenteral nutrition
- •2. Colostomy.
- •3. Patients with small bowel atresia are excluded because of prenatally
- •underdeveloped
- •bowel distal to the atresia.
- •4. Multiple ostomies (more than just an enterostomy and a mucous fistula).
- •5. Patients with chromosomal abnormalities (if known at the time of
- •randomization) are
- •excluded because of potential malabsorption and malnutrition due to an
- •6. Hirschsprung disease secondary exclusion.
- •7. Participation in another drug-intervention study.
- •8. Intestinal perforation due to congenital heart defects with impaired
- •hemodynamics.
研究者
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