| 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
|
|
|
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
|
|
|
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.
|