跳至主要内容
临床试验/NCT02010268
NCT02010268已完成不适用

Evaluation of a Clinico-biological Predictive Score of Enterocolitis and Enteropathy of the Preterm Neonates. Usefulness of the Rapid Assay of the Faecal Calprotectin.

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2013年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
主要终点
fecal calprotectin level

研究概览

简要总结

This study aims to evaluate a clinico-biological predictive score, associating the faecal calprotectin, for the diagnosis of enterocolitis and enteropathy of the preterm neonates.

详细描述

Enteropathy and necrotizing enterocolitis (NEC) are digestive emergencies in premature neonates which represent a major concern for the vital prognosis. It is therefore important to propose a tool for early diagnosis of these intestinal complications in order to avoid extended interruptions of enteral feeding at a period of life where growth (and digestive maturation) is in the foreground. Currently, the diagnosis of digestive impairment is based on classical clinical, biological (CRP, procalcitonin, fecal calprotectin, NFS) and radiological (abdomen without preparation) approaches, which induce on one hand a prolonged interruption of enteral feeding sometimes useless and even harmful for the intestinal maturation and, secondly, the establishment of a parenteral nutrition which is not risk-free. The study propose to dose the fecal calprotectin, a non-invasive marker of digestive inflammation, in order to validate the threshold decision proposed in a pilot study (350 µg/g of feces). Measurement of fecal calprotectin levels will be used as an integrated tool to build a powerful screening score combined to the usual parameters used in routine care for the diagnosis of and enteropathy and necrotizing enterocolitis (NEC) in premature neonates. A cohort of preterm infants born at a gestational age of 33 weeks or less will be included from birth. A stool sample will be collected from the diaper once a week, from birth until discharge from the hospital, and every day during gastrointestinal events (interruption of enteral feeding over 48 hours). The study will evaluate the performance of the rapid assay of fecal calprotectin by quantitative immunochromatography compared to the reference method by enzyme-linked immunosorbent assay (ELISA).

研究设计

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

入排标准

年龄范围
— 至 33 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants prematurely born at a gestational age of 33 weeks or less (or before the 7th month of pregnancy).
  • Patient whose parents or holders of parental authority signed an informed consent.

排除标准

  • Patient with a malformation.
  • Lack of signature of the consent by parents or holders of parental authority.

研究组 & 干预措施

preterm neonates

Experimental

Preterm neonates (birth before 33 weeks of gestation)

干预措施: Collection of stool samples (Other)

结局指标

主要结局

fecal calprotectin level

时间窗: From birth to hospital discharge (3 months maximum).

Quantification of fecal calprotectin in stool samples collected every week and the first 3 days during an interruption over 48 hours of enteral feeding

次要结局

  • Evaluation of the performance of fecal calprotectin rapid assay.(from birth to hospital discharge (3 months maximum))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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