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A Prospective Study: Smart Phone Application for Measure Serum Bilirubin Through Sclera Images

NCT06421844 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2024-05-20

No results posted yet for this study

Summary

The primary efficacy endpoints are the standard deviation and coefficient of determination (R2) between predicted and actual values for the bilirubin regression model, and the grading accuracy for the jaundice severity classification model. The secondary efficacy endpoint is the mean percentage error between predicted and actual bilirubin values. There are no relevant safety risks.

Statistical differences for categorical variables (e.g., jaundice grading evaluation indicators) will be analyzed using the chi-square test or Fisher's exact probability test. For continuous variables (e.g., bilirubin prediction evaluation indicators), t-tests (normal distribution) or non-parametric tests (non-normal distribution) will be used. The 95% confidence interval for jaundice grading accuracy will be calculated using the Wilson method.

The study duration is estimated to be 3 months.

Conditions

  • Jaundice
  • Deep Learning
  • Hyperbilirubinemia
  • Sclera

Sponsors & Collaborators

  • Air Force Military Medical University, China

    lead OTHER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-04-20
Primary Completion
2024-06-20
Completion
2024-07-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06421844 on ClinicalTrials.gov