Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population

April 2, 2024 updated by: Picterus AS
The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The general objective of this study is to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at HICH Mbarara.

The specific objectives for this study are:

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Kampala, Uganda
        • Mengo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Infants born with gestational age ≥37 weeks
  • Birth weight ≥2000g and ≤4500g
  • Age 1 - 14 days
  • Infants requiring a blood sample (newborn screening / clinically suspected jaundice)

Exclusion Criteria:

  • Infants transferred to the paediatric ward for advanced treatment.
  • Infants with a skin rash or other disease that affects the skin where measurements are performed.
  • Infants that receive or have received phototherapy in the last 24 hours.
  • Infants with an inborn disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Enable high qualitative estimation of bilirubin levels in the blood of new-borns
In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors. .
Device: smartphone-based screening tool for neonatal jaundice
In this study we aim to collect data of newborns with wider range of bilirubin levels and high melanin content, and additionally measurements of skin color reflectance with a spectrophotometer, to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smartphone application sensitivity (bilirubin levels on newborns)
Time Frame: 5 minutes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.
Time Frame: 5 minutes
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. Adapt the current algorithm of Picterus JP to newborns with high melanin content in the skin
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Picterus AS

Collaborators

Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2022

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

August 15, 2022

Study Registration Dates

First Submitted

April 28, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IS 145

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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