| CTRI Number |
CTRI/2025/09/095226 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Long-Term Neuro Development in Newborns Affected by Rotavirus Infection |
|
Scientific Title of Study
|
Neurodevelopmental Outcomes in Neonates with Rotaviral Encephalopathy: A Prospective Cohort Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruthi Bharadwaj |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Neonatology, 1st floor, Women and Child Hospital, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
7338321832 |
| Fax |
|
| Email |
skb_bmc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruthi Bharadwaj |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Neonatology, 1st floor, Women and Child Hospital, Kasturba Medical College, Manipal, Udupi
KARNATAKA
576104
India |
| Phone |
7338321832 |
| Fax |
|
| Email |
skb_bmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shruthi Bharadwaj |
| Designation |
Associate Professor |
| Affiliation |
KMC Manipal |
| Address |
Department of Neonatology, 1st floor, Women and Child Hospital, Kasturba Medical College, Manipal, Udupi
KARNATAKA
576104
India |
| Phone |
7338321832 |
| Fax |
|
| Email |
skb_bmc@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Neonatology, Women and Child Hospital, Kasturba Medical College, Manipal, Udupi. Karnataka. 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Neonatology, 1st floor, Women and Child Hospital, Kasturba Medical College, Manipal, Udupi. Karnataka 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 Shruthi Bharadwaj |
Kasturba Medical College |
Department of Neonatology, 1st floor, Women and Child Hospital, Kasturba Medical College, Manipal, Udupi 576104
Udupi
KARNATAKA |
7338321832
skb.bmc@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: P90||Convulsions of newborn, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
Infants who were admitted to the NICU with seizures or encephalopathy. AND
- Diagnosed with positive rotaviral infection (stool PCR) with clinical and MRI brain evidence of encephalopathy. AND
- Parents give consent for follow-up in NICU OPD /High-risk OPD. |
|
| ExclusionCriteria |
| Details |
Neonates with other confirmed central nervous system (CNS) infections or encephalopathy (e.g., meningitis, bacterial encephalitis, Hypoxic ischemic encephalopathy).
- Cases with incomplete medical records or missing follow-up.
- Neonates with genetic or metabolic disorders that could affect neurological outcomes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurodevelopmental outcomes - motor , language and personal social |
1-3 years age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vision, Hearing |
1-3 years age |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/10/2025 |
| 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="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 cohort study involving infants previously admitted to the NICU for seizures or encephalopathy and subsequently diagnosed with rotavirus encephalopathy. Follow-up neurodevelopmental outcomes will be assessed in the NICU highrisk clinic. Parental consent will be obtained from eligible participants. All infants meeting the inclusion criteria will be identified from the NICU and MRD admission-discharge records. Medical records will be accessed from the hospital’s medical records department for NICU data. Parents will be contacted by phone and via mail and are requested to visit the NICU HRFU clinic for neurodevelopmental follow up visits every 3 to 6 months until 3 years of age. Diagnoses will be verified through documented laboratory confirmation of rotavirus infection in the records, along with MRI evidence of rotaviral encephalopathy. Baseline information on demographics, birth history gestational age, birth weight, and clinical presentation age at presentation, symptoms such as seizures or altered mental status) will be recorded. The clinical profile, including symptom onset and duration (documenting when symptoms began and how long they lasted); laboratory and imaging results (including rotavirus test results, complete blood count, biochemical profiles, cerebrospinal fluid CSF analysis if conducted, and electroencephalography EEG and neuroimaging findings of the MRI brain treatment administered type and duration of treatments given, e.g., antivirals, antiepileptics, supportive care); and outcome at NICU discharge neurological status at discharge, resolution of seizures or encephalopathy, and any noted complications will be extracted from the hospital’s electronic and/or physical records. Additional data on any comorbid conditions or congenital abnormalities will also be included. Neurodevelopmental outcomes between 1 and 3 years of age will be evaluated using the Denver Developmental Screening Test DDST. The Developmental Assessment Scale for Indian Infants DASII will be used to further assess motor and mental scores in participants who do not pass the DDST screening test. Data from other neurological assessments during follow-up will also be recorded follow-up imaging, EEG. Participants who are found to have neurodevelopmental issues will be provided with standard treatments with occupational therapy, physiotherapy, speech and language therapy, and vision, and hearing support as standard of care. |