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临床试验/NCT01423786
NCT01423786终止不适用

Early Oral Nutrition in Mild Acute Pediatric Pancreatitis

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
2
主要终点
Tolerance of Oral Nutrition

研究概览

简要总结

This is a prospective trial for children with the diagnosis of mild acute pancreatitis admitted to the hospital for continued management. Patients will be enrolled in the study within 24 hours of admission/diagnosis and will be allowed an oral diet once enrolled. Demographic, laboratory and imaging data done as standard of care will be collected and additional blood work will be sent as part of the study. Patients will be followed prospectively with regards to tolerance to oral nutrition, pain, length of stay and complications. The hypothesis is that patients that are able to tolerate early oral nutrition will have shorter length of stays and will be similar in terms of pain score ratings, readmission rates, complications and the need for invasive supplemental nutrition. Also patients that are able to tolerate early oral nutrition will have less significant elevation of biochemical markers of pancreatitis severity when compared to patients that do not tolerate early oral nutrition and historical controls.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of acute pancreatitis
  • Enroll within 24 hours of diagnosis
  • At least 50% of baseline diet must be taken orally

排除标准

  • Evidence of severe pancreatitis
  • Diagnosis of chronic pancreatitis
  • Patients unable to communicate pain or a desire to eat/drink

结局指标

主要结局

Tolerance of Oral Nutrition

时间窗: 1 week

The time it takes for the patient to tolerate at least 50% of his/her goal oral calories while maintaining hydration as assessed by urine ouput or fluid intake

次要结局

  • Length of Stay(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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