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

NCT05365399 | Terminated

• 1 other identifier: IS 145
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (1)

• Smartphone application sensitivity (bilirubin levels on newborns)

  Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

  5 minutes

Secondary Outcomes (1)

• Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.

  5 minutes

Study Arms (1)

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

OTHER

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

Interventions

smartphone-based screening tool for neonatal jaundice DEVICE

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. .

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Eligibility Criteria

• Age: 24 Hours - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Picterus AS: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Mengo Hospital

Kampala, Uganda

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 Design

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

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 9, 2022
• Study Start: May 3, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

UG (1)