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

April 16, 2024 updated by: Picterus AS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal for this project is to demonstrate that the Picterus Jaundice Pro screening method can be used to identify children with severe neonatal jaundice independent of skin color. Thus, providing a cheaper, patient-friendly, and more readily available method of neonatal jaundice detection. The long-term goal is that with the implementation of the app, the identification of newborns with severe jaundice will be improved and, thus, referred at an earlier stage for diagnostics and treatment.

The study will be a cross-sectional study with quantitative methods of data collection.

The study population will comprise 150 newborns from the Neonatal Unit and the maternity ward at Princess Marina Hospital.

Parents to newborns with and without signs of jaundice will be asked to participate.

Following informed consent, background data such as birth weight, age on examination, gestational age, and type of feeding will be obtained. Gestational age will be based on ultrasound determination and the last normal menstruation period (LNMP). The skin type of the infant will be classified according to the newborn Neomar's scale score.

Transcutaneous bilirubin measurements will be performed over the sternum of the infant. A Dräger Jaundice Meter JM-105 will be used in this study. Skin reflectance will be measured using a portable Konica Minolta spectrophotometer CM-700d.

A validated smartphone with Picterus Jaundice Pro will be used to collect digital images of skin of the infant chest together with the Picterus calibration card. After all the images are obtained, a unique ID will be displayed on the smartphone. This ID will be recorded on the case report forms and later used to pair clinical data and digital images.

A blood sample to determine TSB will be obtained within 60 minutes of obtaining the images and processed at the Department of clinical biochemistry in the hospital laboratory.

After completion of the study the bilirubin measurement from Picterus Jaundice Pro will be determined and compared to the TSB and TCB measurements using the Pearson correlation coefficient. Sub-analysis for the different skin colors will be performed. Systematic over- or under-estimation of bilirubin levels will be evaluated using Bland-Altman plots. Sensitivity and specificity analysis will be calculated for different cut-off values (ROC analysis).

Study Type

Interventional

Enrollment (Actual)

172

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

  • Botswana
      • Gaborone, Botswana
        • Princess Marina 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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gestational age > 37 weeks
  • Birth weight > 2000 g and < 4500 g
  • Age 1-14 days
  • Infants requiring a blood sample for clinically suspected jaundice/screening

Exclusion Criteria:

  • Infants transferred to the pediatric 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: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enable reliable measurement of bilirubin levels in the blood of newborns
to enable reliable measurement of bilirubin levels in the blood of newborns independent of skin color
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.
Other Names:
  • Picterus JP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP.
Time Frame: 1 year
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB
Time Frame: 1-2 hours
Correlate estimates of bilirubin levels obtained by Picterus JP with TSB and TcB in newborns with high melanin content in the skin.
1-2 hours
Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin
Time Frame: 1 year
Determine the sensitivity and specificity of Picterus JP to screen for jaundice in newborns with high melanin content in the skin
1 year

Collaborators and Investigators

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

Sponsor

Picterus AS

Collaborators

University of Copenhagen
University of Botswana

Investigators

  • Principal Investigator: Julie Zimmer, University of Copenhague
  • Study Director: Britt Nakstad, MD, PhD, MSC, Princess Marina Hospital

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)

March 16, 2023

Primary Completion (Actual)

February 26, 2024

Study Completion (Actual)

February 26, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMH 2/11AII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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