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

NCT06372093 | Completed

• 1 other identifier: PMH 2/11AII
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Enable high qualitative estimation of bilirubin levels in the blood of newborns in a population in Botswana using Picterus JP.

  Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.

  1 year

Secondary Outcomes (2)

• Correlation of bilirubin levels obtained by Picterus JP with Tsb and TcB

  1-2 hours

• Sensitivity and specificity of Picterus JP to detect jaundice in newborns with high melanin content in the skin

  1 year

Study Arms (1)

Enable reliable measurement of bilirubin levels in the blood of newborns

EXPERIMENTAL

to enable reliable measurement of bilirubin levels in the blood of newborns independent of skin color

Device: Picterus Jaundice Pro

Interventions

Picterus Jaundice Pro DEVICE

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.

Also known as: Picterus JP

Enable reliable measurement of bilirubin levels in the blood of newborns

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

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

• Picterus AS: lead
• University of Copenhagen: collaborator
• University of Botswana: collaborator

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

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

Study Officials

• Julie Zimmer

  University of Copenhague

  PRINCIPAL INVESTIGATOR

• Britt Nakstad, MD, PhD, MSC

  Princess Marina Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: April 17, 2024
• Study Start: March 16, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BO (1)