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Quick Check of Spinal Fluid Using Simple Urine Test Strips: Comparing It with Standard Lab Tests in Newborns and Children

Bedside cerebrospinal fluid CSF analysis by urine reagent strips and comparison with traditional lab measurements - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/08/093881
Enrollment
125
Registered
2025-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services

Interventions

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Nil

Exclusion criteria

Exclusion criteria: Nil

Design outcomes

Primary

MeasureTime frame
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.Timepoint: Assessment will be done at 4 weeks

Secondary

MeasureTime frame
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.Timepoint: One day

Countries

India

Contacts

Public ContactDr Sham Lohiya

Datta Meghe Institute of Higher Education and Research

sham.lohiya19@gmail.com8098842537

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026