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CTRI Number  CTRI/2025/02/080094 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study to help understand clinical and radiological findings in association with each other, in children of more than 2 months upto 12 years of age to help carry out interventions that may reduce morbidity and mortality. 
Scientific Title of Study   A cross sectional, observational study on clinicoetiological and radiological profile and their association in children with cerebrovascular stroke  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajwanti Vaswani 
Designation  Professor 
Affiliation  Department of Paediatrics, Seth GSMC, KEM Hospital 
Address  Department of Paediatrics, GSMC and KEM Hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone    
Fax    
Email  anukvaswani@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sneha Vaidya 
Designation  Student 
Affiliation  GSMC and KEM Hospital 
Address  Department of Paediatrics, GSMC and KEM hospital, Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9773402165  
Fax    
Email  drsnehaavaidya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sneha Vaidya 
Designation  Student 
Affiliation  GSMC and KEM Hospital 
Address  Department of Paediatrics, GSMC and KEM hospital, Parel


MAHARASHTRA
400012
India 
Phone  9773402165  
Fax    
Email  drsnehaavaidya@gmail.com  
 
Source of Monetary or Material Support  
Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, India 
 
Primary Sponsor  
Name  Dr Rajwanti Vaswani 
Address  Department of Paediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai 400012, Maharashtra, India 
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sneha Vaidya  Seth GS Medical College and KEM Hospital  Ward 1/2, Department of Paediatrics, Old KEM Building
Mumbai
MAHARASHTRA 		 9773402165

drsnehaavaidya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee III, related to Biomedical and Health Research, Seth G. S. Medical College and KEM Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
Comparator Agent  nil   nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1. Children of 1 month to 12 years of age at presentation
2. 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.
3. Children with confirmation of stroke on neuroimaging. 
 
ExclusionCriteria 
Details  Parents not willing to participate
in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Association between clinicoetiological and radiological profile of stroke  at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Early identification & early intervention can be initiated.  1 weeks after clinical diagnosis 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
 
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