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临床试验/CTRI/2025/02/080094
CTRI/2025/02/080094招募中不适用

A cross sectional, observational study on clinicoetiological and radiological profile and their association in children with cerebrovascular stroke

Dr Rajwanti Vaswani1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2025年2月8日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
65
试验地点
1
主要终点
Association between clinicoetiological and radiological profile of stroke

研究概览

简要总结

INTRODUCTION

Stroke is defined as the abrupt or ictal onset of focal or global neurologic symptoms caused by ischemia or hemorrhage within or around the brain resulting from diseases of the cerebral blood vessels(1). The presentation is distinctly different in children, with most cases presenting with seizures. Thus, ongoing challenges exist in development of proven screening tools & diagnostic protocol.(2) It can lead to significant morbidity and mortality even though the incidence is much lower than the adult population.(3) In comparison to adults, fewer studies are available that assess the radiological corelation with the clinicoetiological profile. With recent advances in radiological modalities, a need to co relate it with clinical profiles is seen. Assessing cases from both the clinical as well as radiological point of view will help us understand the condition better, in terms of etiology and recurrence, thus guiding us towards timely intervention. Eventually it will help us prevent the comorbidities usually associated following the event.

AIM: To study the association between clinico-etiological and radiological profiles of children with stroke

PRIMARY OBJECTIVES

To study the clinical profile of stroke in children To study the etiological profile of stroke in children To study the radiological profile of stroke in children

SECONDARY OBJECTIVES

To study association between the clinical and radiological profiles of stroke in children

To study association between the etiological profiles and radiological profiles of stroke in children The sampling method will be purposive. Patient satisfying selection criteria will be taken in study after obtaining informed consent from parents. Children with clinically or radiologically proven stroke using one or more of the following modality (CT/MRI) will be included after screening using the inclusion/exclusion criteria. Clinical and radiological records will be obtained during the patient’s stay at the hospital and filled in a predetermined case format.

STATISTICAL ANALYSIS PLAN

Frequency of Stroke cases presenting to the hospital will be expressed in percentage with 95% CI. Demographic data such as age, gender, socioeconomic status, etc will expressed in percentage of total population studied. These will be categorised individually based on etiological, radiological features and clinical features. Association between these categories, i.e. aetiologies, clinical profiles and radiological profiles will be carried out using Chi Square test. Considering 5% significance, data will be entered and analysed using SPSS(Statistical Package for Social Sciences), v.26 software.

EXPECTED OUTCOMES

Determining the incidence and common presentation/s of pediatric stroke

Understanding common etiology/s involved in cases of pediatric stroke

Describing radiological features of pediatric stroke, suggestive of as well as diagnostic of, stroke, in children.

Analysing the association between their clinical and radiological profiles as well as between clinical and etiological profiles of stroke in children.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children of 1 month to 12 years of age at presentation
  • Children with clinical diagnosis of stroke i.e. rapidly developing signs of focal or global disturbance of cerebral function, lasting for more than 24 hours or leading to death, with no apparent cause other than of vascular origin.
  • Children with confirmation of stroke on neuroimaging.

排除标准

  • Parents not willing to participate in the study.

结局指标

主要结局

Association between clinicoetiological and radiological profile of stroke

时间窗: at baseline

次要结局

  • Early identification & early intervention can be initiated.(1 weeks after clinical diagnosis)

研究者

发起方
Dr Rajwanti Vaswani
申办方类型
Other [self ]
责任方
Principal Investigator
主要研究者

Dr Rajwanti Vaswani

Department of Paediatrics, Seth GSMC, KEM Hospital

研究点 (1)

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