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

NCT06399146 | Recruiting

• 1 other identifier: JZimmer
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to test a novel smartphone application, Picterus, which provides a cheaper, patient-friendly, and more readily means of neonatal jaundice detection. For this purpose, the study aims to collect data from newborns with a broad range of bilirubin levels and high melanin content in a population in Botswana.

Conditions

Neonatal Jaundice; Neonatal Hyperbilirubinemia

Keywords

mhealth

Outcome Measures

Primary Outcomes (2)

• Picterus app estimate

  Estimate of total serum bilirubin in the blood by a smartphone app

  Must be performed within 1 hour of blood sample

• Total serum bilirubin

  Total serum bilirubin determined by a blood sample

  Must be performed within 1 hour of measurement with smartphone app and transcutaneous bilirubinometer

Secondary Outcomes (1)

• Transcutaneous bilirubin

  Must be performed within 1 hour of blood sample

Study Arms (1)

Evaluation of bilirubin estimates in a population in Botswana

EXPERIMENTAL

Compare smartphone estimates of total serum bilirubin in the blood to total serum bilirubin determined through a blood sample.

Device: Picterus App

Interventions

Picterus App DEVICE

Take a photo off the patient's skin (sternum).

Also known as: Picterus smartphone app

Evaluation of bilirubin estimates in a population in Botswana

Eligibility Criteria

• Age: 24 Hours - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age \> 37 weeks
• Birth weight \> 2000 g and \< 4500 g
• Age \> 24 hours and \< 14 days
• Infants requiring a blood sample for clinically suspected jaundice or other screening

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillerod Hospital, Denmark: lead
• Picterus AS: collaborator

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bo M Hansen, prof

  Hillerod Hospital, Denmark

  STUDY CHAIR

Central Study Contacts

Julie Zimmer, stud.med

CONTACT

+4795102393; juzim@online.no

Britt Nakstad, prof

CONTACT

+4793404858; britt.nakstad@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: May 3, 2024
• Study Start: March 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

BO (1)