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临床试验/NCT01674478
NCT01674478已完成2 期

Early Supplementation of Enteral Microlipid With and Without Fish Oil in Premature Infants With Enterostomies

Wake Forest University2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
18
试验地点
2
主要终点
The Serum Biomarkers of Inflammatory Cytokines

研究概览

简要总结

Necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP) are common devastating gastrointestinal diseases in premature infants. These infants often need surgical intervention to remove the dead bowel and create temporary enterostomies, resulting in short bowel syndrome (SBS), a malabsorption state due to insufficient bowel length or dysfunction to digest and absorb nutrients adequately.

These infants are often nourished primarily with parental nutrition (PN) which can lead to many complications including PN-associated liver disease. However, with enteral feeding, the remaining bowel can adapt somewhat to the shortened state, reducing the need for PN. Enteral fats appear to be the most trophic macronutrients with the long chain polyunsaturated fatty acids (LCPUFA) being the most beneficial in promoting bowel adaptation.

Fish oil (FO), a main source of n-3 LCPUFA, has been shown to promote bowel adaptation. Microlipid (ML) primarily contains n-6 PUFA and has been found to decrease ostomy output and increase weight gain in some SBS infants. WThe investigators will soon have completed a randomized clinical trial (EMLFO trial) (WFUHS IRB00011501, NCT01306838) entitled "Early Supplementation of Enteral Lipid with Combination of Microlipid and Fish Oil in Infants with Enterostomies". The preliminary data suggest that (a) by supplementing enteral ML/FO, we were able to decrease the use of IL; (b) premature infants in the treatment group who received ML/FO achieved higher enteral calorie (% of total calorie) intake before reanastomosis and better weight gain (g/day) after reanastomosis than those who received routine care in control group; and (c) the direct bilirubin level before reanastomosis tended to be lower in the treatment group than the control group although the difference was not statistically significant. Because the intervention consisted of both an increase in enteral fat intake as well as a specific type of fat intake (i.e. FO), it is unclear whether improved outcomes in the ML/FO group are attributable to FO's anti-inflammatory effects or the increased fat intake. Therefore, the investigators have designed a next randomized clinical trial to compare ML alone versus ML plus FO. We hypothesize that as compared to ML alone, ML plus FO will result in decreased systemic inflammation, as indicated by blood levels of inflammation-related proteins and indicators of oxidative stress.

详细描述

In comparison to EMLFO trial, the EMLFO-2 study will modify the eligibility criteria to only enroll the infants who have birthweight equal to or less than 1250 g with a jejunostomy or ileostomy as the result of surgical treatment for small intestine perforation or NEC in order to increase the homogeneity of patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Day 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • infants (age range: newborn to ≤ 2-month-old) whose birth weight are ≤ 1250g;
  • who are admitted to BCH NICU for surgical intervention for NEC or small intestine perforation and then to have a jejunostomy or ileostomy;
  • who are expected to need full or partial PN for at least 21days from the day of ostomy placement; and
  • who have received enteral feedings ≤ 4 days since ostomy placement.

排除标准

  • infant with birth weight > 1250g;
  • infant with colostomy;
  • infants with enterostomy but
  • unable to obtain written informed consent from parent;
  • presence of congenital liver, renal, or metabolic diseases or syndromes or perinatal asphyxia;
  • ostomy caused by surgical treatment for a condition other than NEC or small intestine perforation; and
  • unable to initiate enteral feeding for more than 28 days since ostomy placement.

研究组 & 干预措施

Microlipid with fish oil group

Experimental

This group will be given early enteral lipid supplementation with Microlipid and fish oil.

干预措施: Microlipid with fish oil (Dietary Supplement)

Microlipid group

Active Comparator

This group will be given early enteral lipid supplementation only with Microlipid.

干预措施: Microlipid (Dietary Supplement)

结局指标

主要结局

The Serum Biomarkers of Inflammatory Cytokines

时间窗: 2 years and 5 months

Compare the serum biomarkers of inflammatory cytokines of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

The Serum Biomarkers of Oxidative Stress

时间窗: 2 years and 5 months

Compare the serum biomarkers of oxidative stress of the infants receiving ML/FO to the infants only receiving ML between the initial feeding after placement of an ostomy and reanastomosis

次要结局

  • The Average Enteral Calorie (Total Calorie) Intake Before Reanast(2 years and 5 months)
  • The Average Weight Gain (g/Day) After Reanastomosis(2 years and 5 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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