| 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
|
|
|
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
|
|
|
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 |
|
|
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
|
|