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NCT05365399 Clinical Trial

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

Neonatal Jaundice Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05365399
Other study ID # IS 145
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 3, 2022
Est. completion date August 15, 2022

Study information
Verified date April 2024
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 180
Est. completion date August 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 24 Hours to 14 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• 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. .

Locations
Country Name City State
Uganda Mengo Hospital Kampala

Sponsors (2)
Lead Sponsor Collaborator
Picterus AS Norwegian University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 5 minutes
See also
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Completed NCT03306004 - Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho N/A
Completed NCT02774434 - Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age N/A
Recruiting NCT03933423 - Home Based Phototherapy for Neonatal Jaundice N/A
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Completed NCT06227624 - Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia Phase 3
Completed NCT04433923 - Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia in Full Term Infants N/A
Completed NCT04418180 - Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants N/A
Completed NCT06386731 - Continuous Versus Intermittent Phototherapy in Treatment of Neonatal Jaundice N/A
Not yet recruiting NCT05475223 - End Tidal Carbon Monoxide (ETCO): - A Tool to Aid Identification of Neonatal Hemolysis N/A
Recruiting NCT03237715 - Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants N/A