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临床试验/CTRI/2025/04/083760
CTRI/2025/04/083760尚未招募不适用

Single centre observational study of the clinical, etiological, imaging profile and outcome of children admitted with Acute Febrile Encephalopathy in a tertiary care hospital

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
To study the varied causative factors and clinical presentations of acute febrile encephalopathy so as to facilitate early diagnosis and management of the patient

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
29.00 Day(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Consenting primary caregivers of children aged more than 28 days and less than 12 years affected with acute febrile encephalopathy.

排除标准

  • Cases of neurodevelopmental delay, inborn errors of metabolism Known cases of febrile seizures or seizure disorders, hypoxic ischemic encephalopathy and brain tumors.

结局指标

主要结局

To study the varied causative factors and clinical presentations of acute febrile encephalopathy so as to facilitate early diagnosis and management of the patient

时间窗: Till discharge or death of the patient

次要结局

  • Early identification of factors contributing to mortality or detrimental outcomes or clinical improvement of patients(Till discharge or death of the patient)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Jane J E David

Seth G.S. Medical College and KEM Hospital

研究点 (1)

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