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

Picterus AS180 enrolled

Overview

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 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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

180

Conditions

Neonatal Jaundice

Interventions

smartphone-based screening tool for neonatal jaundiceDEVICE

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. .

Eligibility

Sex: ALLMin age: 24 HoursMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Mengo Hospital

Kampala, Uganda

Outcomes

Primary Outcomes

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.

Time frame: 5 minutes

Secondary Outcomes

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

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

Time frame: 5 minutes

Data from ClinicalTrials.gov

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