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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04365998 -
BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice
|
N/A | |
Completed |
NCT02222805 -
Effect of Timing of Umbilical Cord Clamping on Anaemia at 8 and 12 Months and Later Neurodevelopment
|
N/A | |
Completed |
NCT01622699 -
Implementation of a Transcutaneous Bilirubinometer
|
N/A | |
Completed |
NCT00692224 -
Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06080971 -
Persistent Neonatal Jaundice on Neonates and Childern
|
||
Recruiting |
NCT06075290 -
the Difference of Follow-up Methods of Neonatal Jaundice
|
||
Recruiting |
NCT05955144 -
Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones
|
N/A | |
Recruiting |
NCT05127070 -
Evaluating the NeoTree in Malawi and Zimbabwe
|
||
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 | |
Recruiting |
NCT06087874 -
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
|
Phase 2 | |
Recruiting |
NCT06399146 -
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana
|
N/A | |
Recruiting |
NCT03183986 -
Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
|
N/A | |
Withdrawn |
NCT00917007 -
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
|
||
Completed |
NCT06227624 -
Role of Oral Zinc in Reducing Neonatal Indirect Hyperbilirubinemia
|
Phase 3 | |
Completed |
NCT04418180 -
Fenofibrate Therapy in Pathological Unconjugated Hyperbilirubinemia in Full Term Infants
|
N/A | |
Completed |
NCT04433923 -
Aluminium Foil as an Adjuvant to Phototherapy for Pathological Unconjugated Hyperbilirubinaemia 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 |