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

Picterus logo

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems