跳至主要内容
临床试验/NCT03257553
NCT03257553Unknown不适用

Role of Ultrasound ,Doppler and Calprotectin in Diagnosis of Necrotizing Enterocolitis in Neonates

Assiut University0 个研究点目标入组 50 人开始时间: 2018年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
主要终点
diagnosis of necrotizing enterocolitis

研究概览

简要总结

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram)

详细描述

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants. It affects annually 0.72 infants per 1000 live births among all neonates and 33 infants per 1000 live births among very low-birth-weight (below 1500 gram).

Necrotising enterocolitis presents with both gastrointestinal and systemic signs. Gastrointestinal signs as delayed gastric emptying, abdominal distention and bloody stools. Non specific signs as lethargy, apnea, respiratory distress.

Although clinical and characteristic radiological findings remain the most important tools so far. Unfortunately, these signs are usually detectable in an advanced stage of disease.

  • Haematological studies as severe or persistent thrombocytopenia, neutropenia, coagulopathy, or acidosis might indicate severe disease.
  • Serial C-reactive protein : that persistently high C-reactive protein indicated developing complications, such as stricture or abscess.

Unfortunately, the majority of these biomarkers lack accuracy in preclinical stage and do not allow proper discrimination from sepsis Therefore, the search for disease-specific, early and noninvasive diagnostic biomarkers remains warranted.

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

入选标准

  • Include All cases with necrotizing enterocolitis (NEC) in assiut university neonatal intensive care unit (NICU) who are presented with any stage of Bell's stages of necrotising enterocolitis within one year .
  • I. Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs II. Definite disease Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulopathy).

排除标准

  • surgical problems other than NEC ,NEC beyond neonatal period.

研究组 & 干预措施

intervention arm

Experimental

do fecal calprotectin, doppler and ultrasound for each patient

干预措施: fecal calprotectin , doppler and ultrasound (Diagnostic Test)

结局指标

主要结局

diagnosis of necrotizing enterocolitis

时间窗: one year

diagnosis of necrotizing enterocolitis by ultrasound, doppler and calprotectin and compare to see more sensitive and specific method of them in comparison with plain erect

次要结局

未报告次要终点

研究者

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

Azhar Arabi mohammed

principal investigator

Assiut University

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