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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
Picterus AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Jaundice

Eligibility Criteria

24 Hours - 14 Days (Child)All SexesAccepts 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

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

First Posted
April 28, 2022
Last Updated
August 22, 2022
Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology
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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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