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

Picterus

Status: Terminated

Conditions: Neonatal Jaundice

Treatments: Device: smartphone-based screening tool for neonatal jaundice

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05365399

IS 145

Details and patient eligibility

About

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.

Full 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

Enrollment: 180 patients

Sex: All

Ages: 24 hours to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

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

Other group

Description:

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. .

Treatment:

Device: smartphone-based screening tool for neonatal jaundice