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临床试验/NCT06632041
NCT06632041尚未招募不适用

Haematological Disturbances in Neonates with Necrotizing Enterocolities

Assiut University0 个研究点目标入组 70 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Aim

研究概览

简要总结

Haematological disturbances in neonates with necrotizing enterocolities

详细描述

Necrotizing enterocolitis (NEC) is an acquired, multifactorial and devastating gastrointestinal disease associated with high morbidity and mortality in preterm neonates. With an incidence of about 7% in infants with BW < 1500 g and mortality up to 30%, NEC presents as a medical and surgical emergency It is characterized by ischemia, necrosis, and inflammation of bowel wall with invasion by gas-forming organisms and intramural dissection of gas ,characteristicall appearing as pneumatosis intestinalis in radiological and pathological studies. While exact etiology is undetermined, the pathogenesis is believed to be an anomalous innate immune response to an altered, less diverse intestinal microbiota by the highly immunoreactive enterocytes of premature infants, leading to inflammation and tissue necrosis

  • in this devastating disease with undetermined etiology. Breast milk feeding, prolonging gestation to avoid prematurity, antenatal steroid, and the use of probiotics/prebiotics are established prevention strategies in NEC
  • The hematological abnormalities associated with NEC were first described 25 years ago by Hutter et al.The abnormalities observed in a series of 40 patients with NEC included thrombocytopenia, with
  • and without disseminated intravascular coagulation (DIC), neutrophilia or neutropenia, and hemolytic anemia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • preterm less than 36 weeks
  • Or very low birth weight less than 1500 gram

排除标准

  • full term
  • Normal birth weight ,Preterm with early breast feeding or more than 1500 gm

结局指标

主要结局

Aim

时间窗: Baseline

:to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality

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

Mervat maher saad zakhary

Principal investigator

Assiut University

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