Preliminary Registration Detail

Research Registry No : PLRID-00527_V8
 
Postgraduate Research : No
 
University Departmental Research : Yes
 
Name of University : University of Medicine 1, Yangon
 
Department : Department of Neurology
 
Registration Date : 2020-03-05
 
Principle Investigator : WIN MIN THIT
 
Co-Investigators : THEINGI WIN MYAT, SAN OO, OHNMAR, YIN MINN AYE, YAN LYNN AUNG, ZIN PHYU TUN, KYAW PHYO HLAING
 
Title of Research : Spectrum of antecedent infections, immuneJogical status and clinical presentations of Guillain-Barre syndrome at Yangon General Hospital, Myanmar
 
Field of Research : Neurology
 
Preliminary Research Design : Descriptive Study
 
Preliminary Research Type : Applied
 
Preliminary Justification : A number of infections are believed to trigger the GBS, and types and distribution of various infections differ among different countries. Subsequently, the spectrum of causal organisms that will trigger GBS patients in Myanmar might not be the same with other countries data because of different climate and epidemiology of infections in our region. In Myanmar, there is no previous study on spectrum of infection and antigangliosides. This study will help understand the immunopathology of the GBS by identifying the spectrum of antecedent infections causing GBS in correlation with clinical severity, immunology status and outcome. The results from this study will identify the common antecedent infection in GBS patient in Myanmar and whether the types of infection are different from other part of the world. It will be useful as a preliminary step for future research on preventive measures and vaccines to reduce the incidence of GBS in Myanmar.
 
Preliminary Aim : To study the spectrum of antecedent infections, immunological status and clinical outcome of Guillain-Barre syndrome (GBS) cases.
 
Preliminary Objectives : 1. To describe the demographic characteristics of patients with GBS 2. To determine the common antecedent infections causing GBS 3. To assess the clinical severity, immunological status and electrophysiological subtypes in patients with GBS 4. To assess clinical outcome of GBS at 3 months
 
Preliminary Sample Size : According to the hospital registry of Yangon General Hospital, there were 40 patients in 2015 and 50 patients in 2016. The estimated sample size for this study will be 50. All GBS patients will be consecutively recruited according to the inclusion criteria. Inclusion criteria All patients who are diagnosed by Brighton case definitions- criteria.
 
Preliminary Study Duration : May 2018 –May 2019
 
Preliminary Study Area : Department of Neurology, Yangon General Hospital
 
Preliminary Study Method : Hospital based – cross sectional descriptive study
 
Preliminary Research Outcome : demographic characteristics, common antecedent infections causing GBS, immunological status and electrophysiological subtypes in patients with GBS
 
Preliminary Research Finding : Categorical variables will be summarized in proportion, and numerical variables were described in mean (SD) or median as appropriate. GBS disability score of 2 or less will be defined as good outcome and 3 or more will be defined as good outcome.
 
Preliminary Progress Report : : The blood samples of 50 patients have been collected and processed for antiganglioside antibody Ig G & Ig M testing by ELISA (test kit brand- Euroimmun) (Germany) and detection of common possible causal organisms by using serological tests (ELIZA Tests
 
Study Starting Date : 2018-05-01
IRB/PRC/ERC Approval Date : 2020-02-25
 
Placement of IRB/PRC/ERC : University of Medicine 1, Yangon
 
IRB/PRC/ERC Approval Letter/Document : 050320200310192018GBS.pdf
 
Pre-existing Registration ID : 097 / UM1,REC.20I8
 
Pre-existing Name of Organization : Department of Neurology
 
Pre-existing Name of Organization Website : -