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

Not Applicable

Terminated

• Conditions: Neonatal Jaundice
• Interventions: Device: smartphone-based screening tool for neonatal jaundice

• Registration Number: NCT05365399
• Lead Sponsor: Picterus AS

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.

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 Timeline

• Study First Submitted: 2022-04-28
• Study Start: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Primary Completion: 2022-08-15
• Study Completion: 2022-08-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enable high qualitative estimation of bilirubin levels in the blood of new-borns	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. .

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mengo Hospital; 🇺🇬 Kampala, Uganda