Neonatal Jaundice Clinical Trial
Official title:
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
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 |
Verified date | April 2024 |
Source | Picterus AS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Uganda | Mengo Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
Picterus AS | Norwegian University of Science and Technology |
Uganda,
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 |
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