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临床试验/NCT01336998
NCT01336998Unknown不适用

Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine

Alexandra Hospital, Athens, Greece2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
fecal calprotectin levels

研究概览

简要总结

Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker for necrotizing enterocolitis (NEC).

NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly in premature infants. The precise pathophysiology of NEC is unclear ,but major factors thought to play an important role include an immature intestine ,an inflammatory response to intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of NEC is not easy clinically and up to now there is not a simple laboratory test to differentiate NEC at an early stage from other conditions in the neonate.

Arginine is the substrate for NO production in the gut and its deficiency may cause vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine supplementation was found to reduce the incidence of NEC in premature infants but more studies are needed for the use of arginine supplementation for the prevention of NEC.

The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW) infants during the first month of life as an inflammatory marker of the bowel and evaluate whether premature infants receiving arginine supplements had lower calprotectin values compared to the premature infants that did not .

The investigators hypothesize that arginine supplementation in preterm infants reduces the inflammation of the gut which will be shown by the lower fecal calprotectin values of the premature infants receiving arginine supplementation.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 3 Days(Child)
性别
All
接受健康志愿者

入选标准

  • preterm neonates born at Alexandra hospital during the study period
  • < 34 weeks gestational age
  • < 1500gr birth weight

排除标准

  • major congenital abnormalities
  • inborn errors of metabolism
  • parents not consent

结局指标

主要结局

fecal calprotectin levels

时间窗: first 28 days of life

次要结局

  • necrotizing enterocolitis(first 3 months of life)

研究者

发起方
Alexandra Hospital, Athens, Greece
申办方类型
Other

研究点 (2)

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