Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Primary Purpose
Neonatal Jaundice
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
smartphone-based screening tool for neonatal jaundice
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Jaundice
Eligibility Criteria
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
Sites / Locations
- Mengo Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm 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. .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05365399
First Posted
April 28, 2022
Last Updated
August 22, 2022
Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05365399
Brief Title
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Official Title
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm Type
Other
Arm 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. .
Intervention Type
Device
Intervention Name(s)
smartphone-based screening tool for neonatal jaundice
Intervention 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. .
Primary Outcome Measure Information:
Title
Smartphone application sensitivity (bilirubin levels on newborns)
Description
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Smartphone application sensitivity (bilirubin levels on newborns with high melanin content) in the skin.
Description
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
Time Frame
5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mengo Hospital
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Smartphone-based Screening Tool for Neonatal Jaundice in a Ugandan Population
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