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Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana

NCT06372093 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-04-17

No results posted yet for this study

Summary

The general objective of this study is to evaluate the accuracy of a novel smartphone application for jaundice screening (Picterus Jaundice Pro) in a population with high melanin content in the skin.

The specific objectives for this study are:

i. To assess the correlation between bilirubin level measurements obtained by Picterus Jaundice Pro with Total Serum Bilirubin (TSB), and TcB, in newborns with high melanin content in the skin.

ii. To determine the accuracy of Picterus Jaundice Pro in newborns with high melanin content in the skin.

Conditions

  • Jaundice, Neonatal

Interventions

DEVICE

Picterus Jaundice Pro

Picterus Jaundice Pro is a smartphone based screening tool for neonatal jaundice that takes images of the skin of the newborn chest where the Picterus Calibration Card is placed.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • University of Botswana

    collaborator OTHER

  • Picterus AS

    lead INDUSTRY

Principal Investigators

  • Julie Zimmer · University of Copenhague

  • Britt Nakstad, MD, PhD, MSC · Princess Marina Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2024-02-26
Completion
2024-02-26

Countries

  • Botswana

Study Locations

More Related Trials

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 NCT06372093 on ClinicalTrials.gov