| 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
|
|
|
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
|
|
|
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. |