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Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

Primary Purpose

Jaundice, Neonatal

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Picterus Jaundice Pro
Sponsored by
Picterus AS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Jaundice, Neonatal

Eligibility Criteria

0 Days - 14 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Infants born with gestational age >31 Birth weight ≥ 1500g Age 0 - ≤14 days Consent obtained from the parents Exclusion Criteria: Infants born with congenital abnormalities; Infants respiratory support; Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure; Infants who have received phototherapy in the last 24 hours.

Sites / Locations

  • Airlangga University hospital
  • RSIA Kendangsari MERR
  • Dr. Soetomo General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

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 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

Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.

Secondary Outcome Measures

Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
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
Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Full Information

First Posted
November 10, 2022
Last Updated
November 18, 2022
Sponsor
Picterus AS
Collaborators
Airlangga University, RSIA Kendangsaru MERR Surabaya
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1. Study Identification

Unique Protocol Identification Number
NCT05623566
Brief Title
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Official Title
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
November 29, 2018 (Actual)
Study Completion Date
April 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
Collaborators
Airlangga University, RSIA Kendangsaru MERR Surabaya

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
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.
Detailed Description
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya. This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. The Picterus Calibration Card was placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP was used to collect digital images.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
284 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm Type
Experimental
Arm Description
In this study we aim to collect data of newborns with wider range of bilirubin levels 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)
Picterus Jaundice Pro
Other Intervention Name(s)
Picterus JP
Intervention Description
In this study we aim to collect data of newborns with wider range of bilirubin levels 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
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Description
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.
Time Frame
5-10 minutes
Secondary Outcome Measure Information:
Title
Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
Description
To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice
Time Frame
1-2 minutes
Title
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
Description
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
Time Frame
5-10 minutes
Title
Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
Description
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
Time Frame
5-10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Infants born with gestational age >31 Birth weight ≥ 1500g Age 0 - ≤14 days Consent obtained from the parents Exclusion Criteria: Infants born with congenital abnormalities; Infants respiratory support; Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure; Infants who have received phototherapy in the last 24 hours.
Facility Information:
Facility Name
Airlangga University hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60115
Country
Indonesia
Facility Name
RSIA Kendangsari MERR
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60134
Country
Indonesia
Facility Name
Dr. Soetomo General Hospital
City
Surabaya
State/Province
East Java
ZIP/Postal Code
60286
Country
Indonesia

12. IPD Sharing Statement

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Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

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