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

April 2, 2024 updated by: Picterus AS
A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • East Java
      • Surabaya, East Java, Indonesia, 60115
        • Airlangga University hospital
      • Surabaya, East Java, Indonesia, 60134
        • RSIA Kendangsari MERR
      • Surabaya, East Java, Indonesia, 60286
        • Dr. Soetomo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enable high qualitative estimation of bilirubin levels in the blood of new-borns
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.
Device: Picterus Jaundice Pro
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.
Other Names:
  • Picterus JP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.
Time Frame: 5-10 minutes
Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.
5-10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns
Time Frame: 5-10 minutes
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
5-10 minutes
Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns
Time Frame: 5-10 minutes
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
5-10 minutes
Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn
Time Frame: 1-2 minutes
To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice
1-2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Picterus AS

Collaborators

Universitas Airlangga
RSIA Kendangsaru Surabaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2018

Primary Completion (Actual)

November 29, 2018

Study Completion (Actual)

April 29, 2019

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1608Indonesia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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