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CTRI Number  CTRI/2025/10/095805 [Registered on: 09/10/2025] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Predicting outcomes for children with status epilepticus using STEPS Score 
Scientific Title of Study   Clinical profile and outcome prediction in children with Status Epilepticus using STEPSS : Status Epilepticus in Paediatric patients Severity Score 
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 Aditi Somashekar Naidu 
Designation  Junior Resident Department of Paediatrics  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Paediatrics Kasturba Hospital Manipal Tiger Circle Road Madhav Nagar Manipal Karnataka India

Udupi
KARNATAKA
576104
India 
Phone  8310998018  
Fax    
Email  aditisomashekar7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Kumar  
Designation  Associate Professor  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Paediatrics Kasturba Hospital Manipal Tiger Circle Road Madhav Nagar Manipal Karnataka India


KARNATAKA
576104
India 
Phone  8197120018  
Fax    
Email  kumar.sandeep@manipal.edu   
 
Details of Contact Person
Public Query
 
Name  Dr Aditi Somashekar Naidu 
Designation  Junior Resident  
Affiliation  Kasturba Medical College Manipal 
Address  Department of Paediatrics Kasturba Hospital Manipal Tiger Circle Road Madhav Nagar Manipal Karnataka India


KARNATAKA
576104
India 
Phone  8310998018  
Fax    
Email  aditisomashekar7@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal Tiger Circle Road Madhav Nagar Manipal Karnataka 576104 
 
Primary Sponsor  
Name  Not applicable 
Address  Not applicable 
Type of Sponsor  Other [Not applicable ] 
 
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 Aditi Somashekar Naidu  Kasturba Hospital Manipal  Department of Paediatrics, Kasturba Hospital Manipal Madhav Nagar , Manipal Karnataka 576104
Udupi
KARNATAKA 
8310998018

aditisomashekar7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G409||Epilepsy, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children between 1 month to 18 years with status epilepticus admitted to Paediatric Intensive Care Unit of Department of Paediatrics, Kasturba Hospital Manipal 
 
ExclusionCriteria 
Details  Psychogenic non-epileptic seizures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Short term outcome of status epilepticus among children as estimated using the Status Epilepticus in Paediatric patients severity score
 
Status Epilepticus in Paediatric patients severity score will be noted at the time of presentation. 
 
Secondary Outcome  
Outcome  TimePoints 
Disability assessment using the Functional Status scale.  Disability at the time of discharge assessed using the Functional Status scale. 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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)   22/10/2025 
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="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
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  
This project is a prospective, longitudinal study titled Clinical profile and outcome prediction in children with Status Epilepticus using STEPSS Status Epilepticus in Paediatric patients Severity Score.  
The aim is to determine the clinical characteristics and estimate the short term outcome of Status Epilepticus SE using the STEPSS score in children aged 1 month to 18 years admitted to the Paediatric Intensive Care Unit PICU at Kasturba Hospital Manipal.  
The primary objective is to estimate the short term outcome of SE using the STEPSS score. The secondary objectives include determining demographic and clinical factors associated with SE and estimating disability at the time of discharge using the Functional Status Scale FSS.  
The study is justified by the need to identify local etiological factors and optimize clinical care for children with SE, using a simple, validated tool like STEPSS for early risk stratification and outcome prediction. 
Children between 1 month and 18 years with SE admitted to the PICU at Kasturba Hospital, Manipal, will be included, excluding those with psychogenic non epileptic seizures.  
The estimated sample size is 126 and study period between August 2025 to March 2027. The study will use the Status Epilepticus in Paediatric patients Severity Score STEPSS for outcome prediction and the Functional Status Scale FSS to assess disability at discharge. After obtaining Institutional Ethics Committee and CTRI approvals, informed consent will be taken from parents. Clinical data, including demographics, history, physical and neurological examinations, and the STEPSS score will be recorded at admission. Disability at discharge will be assessed using the FSS, with a favourable outcome for children with pre-morbid disability defined as a return to their baseline functional status. Statistical methods will include descriptive statistics, tests for data normality Shapiro-Wilk or Kolmogorov-Smirnov, and the application of parametric or non-parametric tests as appropriate. Predictive accuracy of STEPSS will be tested by calculating specificity, sensitivity, Positive Predictive Value , and Negative Predictive Value , as well as F1 scores. The optimal cut off point will be determined using the Receiver Operating Characteristic curve and Youden’s index.  
Written informed consent will be obtained from parents, and confidentiality will be maintained by not collecting patient details such as name, address, or contact details. The study will not involve any cost as the required EEG is part of the routine standard of care for children with SE.The study is expected to provide better insight into the clinical profile and outcomes of SE using STEPSS and FSS.  
 
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