- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07830927
Early Neurological Outcome in Pediatric Encephalitis
Predictors of Early Neurological Outcome in Children With Encephalitis: A Prospective Study From Assiut University Children Hospital
This prospective cohort study aims to identify baseline clinical, laboratory, and radiological factors at admission that are associated with early neurological outcomes in children with encephalitis admitted to Assiut University Children Hospital.
연구 개요
상세 설명
Encephalitis in children carries a high risk of neurological sequelae. This observational study will include children aged 1 month to 12 years with possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition.
Baseline clinical, laboratory, neuroimaging, and EEG findings will be recorded. Early neurological outcome will be assessed at hospital discharge using the pediatric modified Rankin Scale (mRS).
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Rania A Hussein
- 전화번호: 01280633697
- 이메일: Rania.18313530@med.aun.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Children aged 1 month to 12 years admitted to Assiut University Children Hospital with possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition.
설명
Inclusion Criteria:
- Age from 1 month to 12 years
- Possible or probable encephalitis according to the International Encephalitis Consortium 2013 case definition
- Written informed consent from parents or legal guardians
Exclusion Criteria:
-
Pre-existing severe neurodisability pediatric modified Rankin Scale greater than or equal to 3 before the index illness
- Primary diagnosis of traumatic brain injury or cerebral malaria
- Known inborn error of metabolism or neurodegenerative disorder prior to the encephalitis episode
- Absence of documented neurologic outcome assessment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
Single cohort: Children with encephalitis
Children aged 1 month to 12 years with possible or probable encephalitis who will be assessed for early neurological outcome at hospital discharge using the pediatric modified Rankin Scale. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Functional neurological outcome at discharge
기간: Up to 30 days
|
Score on the pediatric modified Rankin Scale at hospital discharge. The scale ranges from 0 (no symptoms) to 6 (death), with higher scores indicating worse functional outcome |
Up to 30 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Duration of hospital stay
기간: Up to 30 days
|
Length of hospital stay in days. |
Up to 30 days
|
|
Need for intensive care unit admission
기간: Up to 30 days
|
Number of children who require intensive care unit admission |
Up to 30 days
|
|
Need for nasogastric tube feeding at discharge
기간: Up to 30 days
|
Number of children who require nasogastric tube feeding at the time of hospital discharge |
Up to 30 days
|
|
Nosocomial infections
기간: Up to 30 days
|
Number of children who develop nosocomial infections during hospitalization |
Up to 30 days
|
공동 작업자 및 조사자
수사관
- 연구 의자: Faisel A Ahmed, prof, Pediatrics Department, Assiut University Hospitals
간행물 및 유용한 링크
일반 간행물
- Granerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15.
- Venkatesan A, Tunkel AR, Bloch KC, Lauring AS, Sejvar J, Bitnun A, Stahl JP, Mailles A, Drebot M, Rupprecht CE, Yoder J, Cope JR, Wilson MR, Whitley RJ, Sullivan J, Granerod J, Jones C, Eastwood K, Ward KN, Durrheim DN, Solbrig MV, Guo-Dong L, Glaser CA; International Encephalitis Consortium. Case definitions, diagnostic algorithms, and priorities in encephalitis: consensus statement of the international encephalitis consortium. Clin Infect Dis. 2013 Oct;57(8):1114-28. doi: 10.1093/cid/cit458. Epub 2013 Jul 15.
- Pillai SC, Hacohen Y, Tantsis E, Prelog K, Merheb V, Kesson A, Barnes E, Gill D, Webster R, Menezes M, Ardern-Holmes S, Gupta S, Procopis P, Troedson C, Antony J, Ouvrier RA, Polfrit Y, Davies NW, Waters P, Lang B, Lim MJ, Brilot F, Vincent A, Dale RC. Infectious and autoantibody-associated encephalitis: clinical features and long-term outcome. Pediatrics. 2015 Apr;135(4):e974-84. doi: 10.1542/peds.2014-2702.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .