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临床试验/NCT04318353
NCT04318353Unknown不适用

The Effect of Early Enteral Feeding on Neonatal Outcome After Gastrointestinal Tract Surgery

Assiut University0 个研究点目标入组 150 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
主要终点
weight gain

研究概览

简要总结

This study aims to evaluate the effect of early vs late enteral feeding after abdominal surgery on neonatal outcome after surgery, weight gain, length of hospital stay, time to reach full enteral feeding, time to pass first stool, surgical site infections, sepsis and electrolyte disturbances.

详细描述

There are a many reasons for gastrointestinal (GI) tract surgery and following surgery the aim is to efficiently establish infants on enteral feeds and wean them off of parenteral nutrition. Neonates may lose their body resources after surgery due to inadequate nutrient intake and undergoing long periods of fasting after surgery. Nil peroral (NPO)/nil by mouth has been the most commonly practiced convention in post-operative period. Misplaced fear of aspiration, prevent nausea, vomiting and anastomotic complications led to routine prescription of "NPO." The duration of postoperative fasting is variable but can range from 0 to 5 days depending on the operation. The ramifications of this period of fasting are not insignificant and may include prolonged length of stay, increased use of parenteral nutrition (PN), social effects and significant costs to the health system.

Starvation leads to disuse atrophy of villi, decrease disaccharide activity, decreased intestinal mucosa mass, and loss of DNA of enterocyte. This malfunctioning enterocyte leads to increase the permeability of intestinal mucosa to antigen and macromolecules. This starvation-induced gut mucosal injury leads to decrease the production of Vitamin K due to the absence of normal colonic flora. This also leads to decreased growth factors and bile acid metabolism. This compounded effect of starved gut and abnormal colonic bacterial environment leads to colonization of pathological bacteria and might lead to sepsis and sequelae. In addition, starvation leads to decreased immune cells of intestine gut-associated lymphoid tissue. This decreased gut immunity leads to increased uptake of toxins and decreased immune response to foreign antigen. This leads to bacterial translocation Traditionally after abdominal surgery, presence of bowel sounds or passage of flatus or stools has been the clinical evidence of restoration of bowel activity and indicators for starting oral diet. Bowel sounds are poor markers of bowel function as uncoordinated and antegrade peristalsis can be heard as bowel sounds. Currently, there is no good marker for return of bowel sounds, and even in the presence of prolonged ileus, the bowel moves .

Cochrane reviews have shown no advantage in keeping patients "nil by mouth" following gastrointestinal surgery and support early commencement of enteral feeding .

In neonates and infants there are additional issues with delayed feeding including cholestatic jaundice, sepsis, delayed gut development, and metabolic disease. Early trophic feeds may improve recovery time by increasing gut blood flow, improving motility and limiting the impact of starvation on the structure of the gut and its ability to absorb nutrients. Early introduction of enteral nutrition improves intestinal adaptation, reducing the risk of intestinal failure-associated liver disease (IFALD).

ESPEN guidelines recommend early initiation of enteral feeding within 24 h after gastrointestinal surgery, but also state that it needs to be adapted according to the individual tolerance and type of surgery .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • All admitted neonates who undergo abdominal surgery

排除标准

  • Neonates with no-abdominal surgery.
  • Neonates on mechanical ventilation
  • Neonates with other co-morbidities like sepsis, severe respiratory distress, intracranial hemorrhage, birth asphyxia, congenital heart diseases and multiple congenital anomalies

结局指标

主要结局

weight gain

时间窗: One year

Follow up and record of weight after surgery every 24 hours and compaire the results between the two groups

次要结局

  • sepsis(One year)
  • electrolyte disturbances(One year)
  • Time to pass first stool(One year)
  • surgical site infections(One year)
  • Time to reach full enteral feeding(One year)
  • Length of hospital stay(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sandy Nashat Rezk Abaskharon

Principal investigator

Assiut University

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