Early Supplementation of Enteral Lipid With Combination of Microlipid and Fish Oil in Infants With Enterostomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis
研究概览
简要总结
Necrotizing enterocolitis (NEC) and intestinal perforation are common in premature infants. Often surgery is needed to remove the dead bowel and create an ostomy (a temporary intestinal opening on the infant's abdomen). Infants with ostomies cannot digest and absorb food well, and must receive nutrition through the blood stream, i.e. parental nutrition (PN). However, prolonged dependence on PN can severely damage the liver and gut. Therefore, giving nutrition through the gut, i.e. enteral nutrition, is the primary treatment for infants with ostomies.
Enteral fats, especially polyunsaturated fatty acids (PUFA), are most beneficial in stimulating gut mucosal adaptation, which begins 24 to 48 hours following bowel resection. In addition, the premature intestine has a rapid growth rate. It is likely that the current clinical practice of giving a relatively low-fat diet to infants with ostomies may not meet their high metabolic needs.
The investigators hypothesize that increasing dietary fat content by early supplementation with MicroLipid® (ML, n-6 PUFA) and fish oil (FO, n-3 PUFA) to preserve the proper balance of n-6 and n-3 PUFA, may (i) improve bowel adaptation and infant growth; (ii) reduce the use of PN; and (iii) prevent liver damage and/or cholestasis (jaundice) in infants with ostomies.
详细描述
It is an interventional randomized open-labeled controlled trial with two groups:
Treatment group: early supplementation of enteral lipid with ML and FO; Control group: routine care.
The primary goal of this study is to obtain pilot data that will inform the subsequent design and execution of a large, randomized trial which will test the hypothesis that infants with short bowel syndrome or ostomy will experience beneficial growth effects from enteral nutrition supplemented with balanced n6/n-3 PUFA, a simple, inexpensive and noninvasive intervention. This pilot study will confirm the safety of PUFA supplemented enteral nutrition, establish the length and amount of enteral versus parenteral nutrition required, and determine the impact on infant growth and intestinal adaptation by measuring expression of four key genes that play a crucial role in intestinal adaptation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 60 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •infants (age range: newborn to 2-month-old) who are admitted to BCH NICU with a jejunostomy or ileostomy (from surgical intervention for NEC, bowel perforation, midgut volvulus (twisted bowel), atresia or other gastrointestinal surgery);
- •who are expected to need full or partial PN for at least 21days from the day of enterostomy placement; and
- •have received enteral feedings ≤ 4 days since enterostomy placement
排除标准
- •infant with colostomy;
- •infants with enterostomy but
- •unable to obtain written informed consent from parent;
- •presence of congenital liver or renal, or metabolic diseases; and
- •ostomy caused by gastroschisis, omphalocele, imperforate anus, and perinatal asphyxia
- •unable to initiate enteral feeds after 28 days of ostomy placement.
研究组 & 干预措施
Treatment
The treatment arm is given early enteral supplementation with MicroLipid and Fish oil.
干预措施: MicroLipid and fish oil (Dietary Supplement)
Control Group
Routine care
干预措施: Routine care (Other)
结局指标
主要结局
Average duration of exposure to PN (including Intralipid, IL) between the initial feeding and bowel reanastomosis
时间窗: up to three years
We hypothesize that the average duration of exposure to PN/IL of the infants receiving ML/FO will be less than that of infants receiving usual care. The ratio of enteral to parenteral nutrition in the infants receiving ML/FO will be greater than that of infants receiving usual care.
次要结局
- Expression of four key genes that play a crucial role in intestinal adaptation(up to four years)
- Average level of conjugated bilirubin and ostomy output of infants receiving ML/FO to the group receiving usual care between the initial feeding after placement of ostomy and reanastomosis(up to three years)
- Dietary fat and protein absorption, from initiating feeding to reanastomosis(up to three years)
- Average weight gain (g/day)from initiating feeding to reanastomosis(up to three years)
- Neurodevelopment outcomes and growth in the infants receiving ML/FO vs. in the infants receiving usual care at the 18-24 month of age.(up to 4.5 years)