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CTRI Number  CTRI/2025/11/097463 [Registered on: 14/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A trial to compare online doctor consultation versus hospital visit consultation for children with infantile spasms (a type of difficult infantile epilepsy) 
Scientific Title of Study   Comparison of telemedicine versus in-person follow-Up in children with infantile epileptic spasms syndrome (IESS): A Randomized controlled trial (Tele-IESS Trial) 
Trial Acronym  Tele-IESS Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jitendra Kumar Sahu  
Designation  Professor  
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh  
Address  Room 5108, 5A, Advanced Pediatric Center, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009202  
Fax    
Email  jsh2003@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jitendra Kumar Sahu  
Designation  Professor  
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh  
Address  Room 5108, 5A, Advanced Pediatric Center, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009202  
Fax    
Email  jsh2003@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jitendra Kumar Sahu  
Designation  Professor  
Affiliation  Postgraduate Institute of Medical Education and Research, Chandigarh  
Address  Room 5108, 5A, Advanced Pediatric Center, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009202  
Fax    
Email  jsh2003@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) project grant 
 
Primary Sponsor  
Name  Indian Council of Medical Research (ICMR) 
Address  Ansari Nagar, New Delhi-110029 
Type of Sponsor  Government funding agency 
 
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 
Jitendra Kumar Sahu  Post Graduate Institute of Medical Education & Research  Room no. 5108, 5A, 5th Floor, Pediatric Neurology Unit, Advanced Pediatric Centre
Chandigarh
CHANDIGARH 		 07087009202

jsh2003@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G404||Other generalized epilepsy and epileptic syndromes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  In-person follow-up  In-person follow-up as usual care will be continued in comparator arm 
Intervention  Telemedicine  Synchronus (audio-visual) form of telemedicine will be used for remote follow-up 
 
Inclusion Criteria  
Age From  2.00 Month(s)
Age To  24.00 Month(s)
Gender  Both 
Details  1. Confirmed diagnosis of IESS as per ILAE
2. Newly started on ACTH therapy.
3. Parents or caregivers willing to participate and provide informed consent.
4. Access to a smartphone/internet
5. Resides more than 10km distance from our institute
 
 
ExclusionCriteria 
Details  1. Prior history of ACTH or steroid therapy for epilepsy.
2. Structural brain abnormalities requiring urgent neurosurgical intervention.
3. Severe comorbidities needing hospital admission (e.g., sepsis, metabolic crisis).
4. Parents are unlikely to adhere to a follow-up schedule.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Epileptic spasms-free rate, as reported by parents at 1, 2, and 6 weeks and validated by EEG resolution using BASED scoring at 6 weeks post-treatment.  Outcomes measured at 1, 2, and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess caregiver burden (Zarit Burden Interview) and parental QoL (EQ-5D-5L) at 2- and 6-weeks post-treatment, comparing TMF and IPF groups.  Zarit Burden Interview scores at baseline, 2 and 6 weeks post-treatment and parental QoL at baseline and 6 weeks 
To measure adherence to ACTH therapy using MARS-5 at 6 weeks post-treatment for both groups.  At six weeks 
To analyze telemedicine follow-up cost-effectiveness versus in-person follow-up by assessing direct/indirect costs and identifying implementation barriers through qualitative interviews at study completion.  Assessed over completion of 6 weeks 
 
Target Sample Size   Total Sample Size="146"
Sample Size from India="146" 
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)   10/12/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response (Others) -  Not decided

  4. For what types of analyses will this data be available?
    Response (Others) -  Not decided

  5. By what mechanism will data be made available?
    Response (Others) -  Not decided

  6. For how long will this data be available start date provided 01-10-2028 and end date provided 31-12-2029?
    Response (Others) -  Not decided

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Telemedicine is an increasingly feasible alternative to in-person care for chronic conditions like epilepsy, especially in settings where distance limits access. However, its use in Infantile Epileptic Spasms Syndrome (IESS) is challenging because patients require daily injectable hormonal therapy, frequent monitoring, and EEG assessments. Timely treatment is crucial for neurodevelopment, but in low- and middle-income countries, access is often limited by a scarcity of child neurologists and travel burdens, resulting in high loss-to-follow-up. This proof-of-concept, randomized controlled study evaluates the feasibility of telemedicine-based follow-up in IESS and directly compares its efficacy, safety, cost-effectiveness, and impact on quality of life to standard in-person follow-up.


 
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