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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 17
- 主要终点
- Time to full enteral feeds (hours)
研究概览
简要总结
The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.
详细描述
Enterostomies in children may be created for different reasons. During the presence of an enterostomy the regular stool transfer is interrupted as the distal part of the bowel (the part following the enterostomy) does not participate in the circulation of stool. Therefore it does not contribute to the resorption of enteral contents. As a consequence these children need additional parenteral nutrition. Due to the negative side-effects of parenteral nutrition all patients should return to enteral nutrition as soon as possible. Consequently, many pediatric surgical centers worldwide routinely perform mucous fistula refeeding (MFR) into the former unused bowel after enterostomy creation because case reports and retrospective analyses show low complication rates and faster postoperative weight gain. Several providers, however, shy away from this approach because to date there is still no high quality evidence for the benefit of this Treatment.The aim of this study is to assess the effects of mucous fistula refeeding in a randomized, prospective trial. We hypothesize that MFR between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to the group without refilling. Moreover, the side effects of parenteral nutrition may be reduced and the postoperative hospital care of infants undergoing ostomy closure shortened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants < 366 days,
- •Ileostomy / Jejunostomy,
- •double loop enterostomies and split enterostomies (with mucous fistula)
- •Signed written informed consent obtained by parents/legal guardians and willingness of parents/legal guardians to comply with treatment and follow-up procedures of their child
排除标准
- •resection of ileocecal valve,
- •small bowel atresia,
- •multiple ostomies (more than just an enterostomy and a mucous fistula),
- •chromosomal abnormalities (if known at the time of randomization),
- •Hirschsprung's disease,
- •participation in another drug-intervention study
- •Intestinal perforation due to a hemodynamic heart defect
研究组 & 干预措施
No mucous fistula refeeding
No perioperative mucous fistula refeeding
Perioperative mucous fistula refeeding
Perioperative mucous fistula refeeding between enterostomy creation and enterostomy closure
干预措施: mucous fistula refeeding (Other)
结局指标
主要结局
Time to full enteral feeds (hours)
时间窗: week 4 to week 12 daily
Time to full feeds (hours), defined as time to actual enteral intake of the age-dependent caloric requirements per day (defined as 90 or 120kcal/kg/24h) for at least 24 hours and a concomitant reduction of parenteral fluids to \<20ml/kg/24h. 1. The nutrition aim is 120 kcal/kg/24h for premature infants with a birth weight \< 1000g or premature infants with a birth weight ≥ 1000g and mother's gestation week at birth before 37+0. 2. The nutrition aim is 90 kcal/kg/24h for born mature infants, mother's gestation week at birth at least 37+0.
次要结局
- Postoperative weight gain (g/d)(week 4 to week 12)
- Assessment of serious adverse events (SAEs)(Week 1 to week 12 daily, follow-up (month 3, 6, 12))
- Sodium resorption(Week 1 to week 12 daily, follow-up (month 3))
- Time to first bowel movement(Week 4 to week 12 daily)
- Number of days of postoperative total parenteral nutrition (TPN)(Week 2 to week 12 daily, follow-up (month 3, 6, 12))
- Assessment of adverse events (AEs)(Week 1 to week 12 daily, follow-up (month 3, 6, 12))
- Laboratory parameters(Week 1 to week 12 daily, follow-up (month 3))
- Thriving(Week 1 to week 12 daily; follow-up (month 3, 6, 12))
- Status of liver enzymes(Week 1 to week 12 daily, follow-up (month 3))
- Time to full volume intake per day (in hours)(week 4 to week 12 daily)
- Z-Score (standard deviation score)(Week 1 to week 12 daily, follow-up (month 3, 6, 12))
- Laboratory parameter indicating cholestasis(Week 1 to week 12 daily, follow-up (month 3))
- Central venous line (CVL)(Week 1 to week 12)
- hospitalisation(week 1 to week 12)
- jump in caliber(week 5)
研究者
Martin Lacher
Prof. Dr. med.
University of Leipzig