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临床试验/NCT01464866
NCT01464866已完成3 期

Effect of Nutritional Supplementation on Pediatric Burn Patients

Abbott Nutrition18 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
116
试验地点
18
主要终点
prealbumin

研究概览

简要总结

This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.

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
1 Year 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1-10 years of age
  • Hospital admission within 24 hours post-burn
  • At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
  • Capable of exclusive oral feeding within 3 days of hospitalization
  • Expected to be hospitalized at least 14 days

排除标准

  • History diabetes or stress-induced hyperglycemia
  • Artificial ventilation
  • Requires parenteral or enteral feeding
  • Drug that affects metabolism
  • Receiving Dialysis
  • Acutely impacted or constipated
  • Consumes non-study nutritional supplement
  • Allergy or intolerance to any study product ingredient
  • Participating in non-Abbott approved concomitant trial

结局指标

主要结局

prealbumin

时间窗: Change between Baseline and Day 14

次要结局

  • C Reactive Protein(Between baseline and Day 14)
  • Preablumin(Change between Baseline and Day 7)
  • C Reactive Protein (CRP)(Between baseline and Day 7)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (18)

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