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CTRI Number  CTRI/2025/04/083760 [Registered on: 01/04/2025] Trial Registered Prospectively
Last Modified On: 30/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study for children who are admitted with acute febrile encephalopathy - a condition associated with fever and brain dysfunction in a tertiary care hospital 
Scientific Title of Study   Single centre observational study of the clinical, etiological, imaging profile and outcome of children admitted with Acute Febrile Encephalopathy in a tertiary care hospital  
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 Jane J E David  
Designation  Associate professor  
Affiliation  Seth G.S. Medical College and KEM Hospital  
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9869146151  
Fax    
Email  janejackiedavid@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jane J E David  
Designation  Associate professor  
Affiliation  Seth G.S. Medical College and KEM Hospital  
Address  Department of Pediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Hospital Building, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  9869146151  
Fax    
Email  janejackiedavid@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Shruti Patil  
Designation  Junior Resident  
Affiliation  Seth G.S. Medical College and KEM Hospital 
Address  Department of Paediatrics, Seth G.S. Medical College and KEM Hospital, Old KEM Building, Parel, Mumbai.

Mumbai
MAHARASHTRA
400012
India 
Phone  8452039311  
Fax    
Email  pat04shruti@gmail.com  
 
Source of Monetary or Material Support  
Seth G S Medical College and KEM Hospital Mumbai 400012 India 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 Jane J E David   Seth G S Medical College and KEM Hospital  Pediatric ward and Pediatric Intensive Care Unit, Old KEM Hospital Building, Ground floor, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9869146151

janejackiedavid@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G04||Encephalitis, myelitis and encephalomyelitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  29.00 Day(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Consenting primary caregivers of children aged more than 28 days and less than 12 years affected with acute febrile encephalopathy. 
 
ExclusionCriteria 
Details  Cases of neurodevelopmental delay, inborn errors of metabolism
Known cases of febrile seizures or seizure disorders, hypoxic ischemic encephalopathy and brain tumors.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the varied causative factors and clinical presentations of acute febrile encephalopathy so as to facilitate early diagnosis and management of the patient   Till discharge or death of the patient  
 
Secondary Outcome  
Outcome  TimePoints 
Early identification of factors contributing to mortality or detrimental outcomes or clinical improvement of patients   Till discharge or death of the patient  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   20/04/2025 
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="1"
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  

Aim:

The aim of this thesis is to comprehensively investigate the clinical presentation, neuroimaging findings, and outcomes of children admitted with acute febrile encephalopathy in a tertiary care hospital.


 

Objectives:

Primary objective - 

To study the clinical profile and etiology of acute febrile encephalopathy in children. 

Secondary objective -

To evaluate factors associated with mortality and neurologic sequelae on discharge.

 

 

                                        Research questions

 

1. What are the common clinical features observed in children admitted with acute febrile encephalopathy, and how do these presentations vary across different etiological factors?

2. What are the neuroimaging findings seen in children with acute febrile encephalopathy, and how do these findings correlate with clinical symptoms and outcomes?

3. What are the predominant etiological factors contributing to acute febrile encephalopathy in pediatric patients, and what is the distribution of infectious versus non-infectious causes?

4. What are the short-term and long-term clinical outcomes of children admitted with acute febrile encephalopathy, including mortality rates, neurological sequelae, and functional disability?

5 .Are there identifiable biomarkers in blood, cerebrospinal fluid, or neuroimaging studies that correlate with disease severity, treatment response, and long-term prognosis in children with acute febrile encephalopathy?

                             

 

Selection Criteria

 

Inclusion criteria

1. Children aged more than 28 days and less than 12 years affected with acute febrile encephalopathy. 

 

Exclusion criteria

1. Cases of neurodevelopmental delay, inborn errors of metabolism.

2. Known cases of febrile seizures or seizure disorders, hypoxic ischemic encephalopathy and brain tumors.

 

 

Materials and methods

 

Ethics- Approval from IEC will be obtained prior to the commencement of the study.

Consent- Written, informed consent from caregivers of study participants will be obtained as per the ICMR National Ethical guidelines for Biomedical and Health Research involving Human Participants 2017.

Study type – Single centre, observational cross sectional study.

Confidentiality – The personal details of participants will be kept confidential and will not be mentioned in the study.

Setting- Ward and ICU of Department of Paediatrics .

Study duration – 15 months for data collection and 3 months for analysis.


Expected outcomes

The expected outcomes of a research study on the clinical, imaging profile, and outcome of children admitted with acute febrile encephalopathy in a tertiary care hospital may include:

1. Comprehensive Understanding of Clinical Presentation: Identification and documentation of common clinical features and symptomatology associated with acute febrile encephalopathy in pediatric patients, leading to improved recognition and diagnosis of the condition.
2. Insight into Neuroimaging Findings: Characterization of neuroimaging findings, including structural abnormalities, inflammatory changes, and infectious processes affecting the central nervous system, providing insights into the underlying pathophysiology and aiding in differential diagnosis.
3. Etiological Insights: Determination of the predominant etiological factors contributing to acute febrile encephalopathy in children, including infectious and non-infectious causes, which may inform targeted diagnostic evaluations and therapeutic interventions.
4. Clinical Outcome Analysis: Evaluation of short-term and long-term clinical outcomes, including mortality rates, neurological sequelae, cognitive impairment, and functional disability, facilitating prognostication and guiding follow-up care and rehabilitation strategies.
5. Identification of Predictive Biomarkers: Discovery of potential biomarkers in blood, cerebrospinal fluid, or neuroimaging studies that may serve as indicators of disease severity, treatment response, and long-term prognosis, enabling personalized management approaches and early intervention strategies.
6. Enhanced Clinical Management: Integration of research findings into clinical practice to improve diagnostic accuracy, optimize therapeutic strategies, and ultimately enhance patient care and outcomes in pediatric acute febrile encephalopathy cases.

Overall, the expected outcomes of this research study aim to advance our understanding of acute febrile encephalopathy in children, leading to improved diagnostic and management strategies and ultimately better outcomes for affected patients.

 

 

References

1.Gupta K, Purani CS, Mandal A, Singh A. Acute febrile encephalopathy in children: A prospective study of clinical features, etiology, mortality, and risk factors from western India. Journal of neurosciences in rural practice. 2018;9(01):019-25. 

2.Shah C, Makwana P. Study of Acute Febrile Encephalopathy among Children in Tertiary Care Centre. Ann. Int. Med. Den. Res. 2019; 5(5):PE01- PE04.

3.Deepthi A, Bekkam M. Study on clinical profile and etiology of acute febrile encephalopathy in children aged between 2 months to 14 years attending to a tertiary care hospital, Eluru, Andhra Pradesh, India. International Journal of Pediatric Research. 2018;5(11).

4.Modi A, Atam V, Jain N, Gutch M, Verma R. The etiological diagnosis and outcome in patients of acute febrile encephalopathy: a prospective observational study at tertiary care center. Neurology India.2012;60(2):168-73.

5.Biswas R, Basu K, Tripathi I, Roy SK. A study on etiology, clinical profile and outcome of acute febrile encephalopathy in children: A prospective study at a tertiary care center of Eastern India. Asian J Med Sci. 2021;12(4):86-91.

6. Roy A, Mandal K, Sen S, Bag T. Study of acute viral meningoencephalitis in children in sub-Himalayan Tarai region: Clinico-epidemiological, etiological, and imaging profile. Indian Journal of Child Health.2015; 29;2(4):177-81.

7. De S, Samanta S, Halder S, Sarkar P. Clinical profile and outcome of children admitted with acute encephalitis syndrome in a tertiary care hospital in West Bengal, India. Hemoglobin (Gm/dl). 2015;11(11):1-8.

 

8. Habibur RC, Foiz M, Jahangir HM, Uddin AK, Mahmudur R. Acute meningoencephalitis in hospitalised children in southern Bangladesh. The Malaysian journal of medical sciences: MJMS.2012;19(2):67.

9.Bokade CM, Gulhane RR, Bagul AS, Thakre SB. Acute febrile encephalopathy in children and predictors of mortality. Journal of Clinical and Diagnostic Research: JCDR. 2014;8(8):PC09.

10.Kalita J, Mani VE, Bhoi SK, Misra UK. Spectrum and outcome of acute infectious encephalitis/encephalopathy in an intensive care unit from India. QJM: An International Journal of Medicine. 2017;110(3):141-8.

11.De Blauw D, Bruning AH, Wolthers KC,Van Wermeskerken AM, Biezeveld MH, Wildenbeest JG, et al. Incidence of childhood meningoencephalitis in children with a suspected meningoencephalitis in the Netherlands.The Pediatric Infectious Disease Journal.2022;1;41(4):290-306.

12. Mizuguchi M, Ichiyama T, Imataka G, Okumura A, Goto T, Sakuma H,et al. Guidelines for the diagnosis and treatment of acute encephalopathy in childhood. Brain and Development. 2021;43(1):2-31.

13. Anga G, Barnabas R, Kaminiel O, Tefuarani N, Vince J, Ripa P, Riddell M, Duke T. The aetiology, clinical presentations and outcome of febrile encephalopathy in children in Papua New Guinea. Annals of tropical paediatrics. 2010;1;30(2):109-18.

14.Aneja S, Sharma S. Diagnosis and Management of Acute Encephalitis in Children. Indian J Pediatr. 2019;86(1):70-75.

15. Lohitharajah J, Malavige N, Arambepola C, Wanigasinghe J, Gamage R, Gunaratne P, Ratnayake P, Chang T. Viral aetiologies of acute encephalitis in a hospital-based South Asian population. BMC Infect Dis. 2017;24;17(1):303.


 

 
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