跳至主要内容
临床试验/NCT06559410
NCT06559410尚未招募不适用

A Descriptive Study on Convulsions in Neonates With Congenital Heart Diseases at Assiut University Children Hospital

Assiut University0 个研究点目标入组 80 人开始时间: 2024年8月10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
80
主要终点
analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures

研究概览

简要总结

analyze the etiology, electroencephalographic (EEG) findings, neuroimaging, and neurological sequalae of newborns with congenital heart disease who were presented with seizures during their neonatal intensive care unit admission.

详细描述

Neonatal seizures are a commonly encountered neurologic condition in neonates. They are defined as the occurrence of sudden, paroxysmal, abnormal alteration of electrographic activity at any point from birth to the end of the neonatal period. During this period, the neonatal brain is developmentally immature. Thus, neonatal seizures have unique pathophysiology and electrographic findings resulting in clinical manifestations that can be different (and more difficult to identify) when compared to older age groups.

Neonatal seizures are paroxysmal, repetitive and stereotypical events. They are usually clinically subtle, inconspicuous and difficult to recognize from the normal behaviors of the inter-ictal periods or physiological phenomena. There is no recognizable post-ictal state. The most widely used scheme is of five main types of neonatal seizure.

  • Subtle seizures (50%)
  • Tonic seizures (5%)
  • Clonic seizures (25%)
  • Myoclonic seizures (20%)
  • Non-paroxysmal repetitive behaviors Neonates with congenital heart disease have a high risk of cerebral lesions, seizures, and neurological impairment. By congenital heart disease, we refer to the group of congenital malformations present at birth that include cyanotic as well as non-cyanotic cardiac lesions.

Neonatal seizures are the most common clinical expression of central nervous system dysfunction in newborns and one of the most frequent neurological emergencies during this stage of life. They are usually the first sign of neurological involvement and an indicator of the risk of mortality and/ or neurological sequelae.

研究设计

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

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

  • All neonates up to 28 days of age with congenital heart diseases presented with repeated seizures admitted to Neonatology unit at Assiut university children hospital

排除标准

  • Neonates with normal heart or infants more than 28 days of age.

结局指标

主要结局

analyze the electroencephalographic (EEG) finding and neuroimaging of newborns with congenital heart disease who were presented with seizures

时间窗: baseline

neuroimaging including Brain MSCT

analyze the etiology of seizures in newborns with congenital heart disease

时间窗: baseline

analyze the etiology of seizures whether it is related to hypoxia, electrolytes disturbances, heart failure or any other casue

state neurological sequalae of newborns with congenital heart disease who were presented with seizures

时间窗: baseline

state if there is any neurological sequalae

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

Mariam Mohamed Mohamed Abdelhameed

Pediatric resident doctor

Assiut University

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