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CTRI Number  CTRI/2025/12/098850 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 08/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Signs and symptoms of Seizures in newborns and their short term outcomes 
Scientific Title of Study   Clinical features and short term outcomes in neonates with seizures 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jahnavi Jain 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal  
Address  Department Of Paediatrics Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  7021014920  
Fax    
Email  jahnavi.jain123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jayashree Purkaystha 
Designation  Professor 
Affiliation  Kasturba Medical College Manipal  
Address  Department Of Paediatrics Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9886249133  
Fax    
Email  jaya.p@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Jahnavi Jain 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal  
Address  Department Of Paediatrics Kasturba Medical College Manipal

Udupi
KARNATAKA
576104
India 
Phone  7021014920  
Fax    
Email  jahnavi.jain123@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, India- 576104 
 
Primary Sponsor  
Name  Kasturba Hospital Manipal 
Address  Department of Paediatrics, Kasturba Medical College, Manipal, Karnataka, India- 576104 
Type of Sponsor  Private medical college 
 
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 Jahnavi Jain  Kasturba Hospital, Manipal  NICU, 2nd floor, women and child block, Department of Paediatrics, Kasturba Hospital, Manipal
Udupi
KARNATAKA 
7021014920

jahnavi.jain123@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- 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P90||Convulsions of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Term Neonates with seizures occurring within the first 28 days of life admitted to NICU  
 
ExclusionCriteria 
Details  Neonates with seizure like phenomenon without other evidence of seizure activity (without EEG correlation), these clinical events can be jitteriness, exaggerated startle, etc;
Neonates with major congenital anomalies except CNS Malformations
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Short-term outcome assessment at discharge (normal, abnormal neurological examination)
Number of anticonvulsants at discharge
Feeding pattern at discharge
 
Outcomes will be assessed at discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
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)   20/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - NO
Brief Summary  

This is a prospective observational study conducted in a tertiary care neonatal intensive care unit over a period of  2 years. The study will include term neonates who develop seizures within the first 28 days of life. A total sample size of 105 neonates has been calculated. The study aims to describe the clinical profile, causes, and short term outcomes of neonatal seizures and to identify factors that may predict poor neurological outcome at discharge. Detailed clinical history, examination findings, seizure characteristics, laboratory investigations, EEG findings, and neuroimaging results will be recorded. Seizures will be classified as per the ILAE neonatal seizure classification. All infants will receive standard treatment as per NICU protocol and no additional procedures will be performed as part of the study. Statistical analysis will be performed to identify associations between seizure types, underlying causes, EEG abnormalities, and short term outcomes. The study is expected to provide useful information relevant to early diagnosis, management, and counseling of families in settings with limited diagnostic resources. Ethical approval and written informed consent from parents or guardians will be obtained.


 
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