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CTRI Number  CTRI/2025/08/093881 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On: 28/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Quick Check of Spinal Fluid Using Simple Urine Test Strips: Comparing It with Standard Lab Tests in Newborns and Children 
Scientific Title of Study   Bedside cerebrospinal fluid CSF analysis by urine reagent strips and comparison with traditional lab measurements 
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 Shahzad Ahmad 
Designation  Junior Residence 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Pediatrics, 2nd floor, AVBRH Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone    
Fax    
Email  drshahzad07@outlook.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sham Lohiya 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Pediatrics, 2nd floor, AVBRH Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  8098842537  
Fax    
Email  sham.lohiya19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sham Lohiya 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Pediatrics, 2nd floor, AVBRH Building, Sawangi Meghe

Wardha
MAHARASHTRA
442001
India 
Phone  8098842537  
Fax    
Email  sham.lohiya19@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India 442001 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 Shahzad Ahmad  Acharya Vinoba Bhave Rural Hospital  Department of Pediatrics, 2nd floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA 
9026889569

drshahzad07@outlook.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education & Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  None  None 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  2.00 Year(s)
Gender  Both 
Details  Nil 
 
ExclusionCriteria 
Details  Nil 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is to assess the accuracy of urine reagent strips in detecting cerebrospinal fluid (CSF) abnormalities, specifically protein, glucose, and leukocyte esterase, in comparison to traditional laboratory measurements. The study aims to determine the reliability of urine reagent strips as a tool for semi-quantitative CSF analysis.   Assessment will be done at 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcomes include evaluating the sensitivity and specificity of urine reagent strips for different cutoff values in detecting CSF protein, sugar, and cells. Diagnostic performance metrics, such as positive and negative predictive values, along with likelihood ratios, will be calculated to provide a comprehensive understanding of the utility of urine reagent strips in CSF examination. Additionally, the study will explore the optimal cutoff levels through the analysis of CSF protein, sugar, and neutrophil counts, using receiver operating characteristic (ROC) curves. Comparative assessments between urine reagent strip values and traditional laboratory measurements will be conducted, and an exploratory analysis will be carried out to understand the potential impact of rapid bedside assessment on patient prognosis and outcomes.  One day 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   26/09/2025 
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 Yet Recruiting 
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 study aims to evaluate the utility of urine reagent strips for bedside cerebrospinal fluid (CSF) analysis, comparing their accuracy with traditional laboratory measurements. In settings where access to advanced laboratory facilities is limited, rapid and reliable diagnostic tools are crucial. The study, conducted over a two-year period at AVBRH hospital in Maharashtra, focuses on neonatology and paediatrics patients undergoing CSF examination. The primary objective is to assess the accuracy of urine reagent strips in semi-quantitative analysis of CSF protein, glucose, and leukocyte esterase. Secondary objectives involve comparing strip values with laboratory measurements, studying the accuracy for different cutoff values, and determining the sensitivity and specificity for CSF protein, sugar, and cells. A sample size of 125 patients was calculated based on the sensitivity and specificity of the reagent strip method, considering a prevalence of meningitis, precision, and a confidence level of 95%. Ethical approval has been obtained, and the study will include patients diagnosed with CNS infection. The methodology encompasses CSF microscopy, biochemical analysis, and urine reagent strip tests. Statistical analyses will employ diagnostic accuracy measures and construct receiver operating curves to determine optimal cutoff levels. This study holds promise for providing a rapid and feasible approach to CSF analysis in resource-constrained healthcare settings.

 
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