Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia

July 13, 2023 updated by: Picterus AS

The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:

  • Demonstrate that Picterus system performs accurately in Indonesian newborns
  • Ensure that Picterus is in line with users' needs in Indonesia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:

  • Demonstrate that Picterus system performs accurately in Indonesian newborns
  • Ensure that Picterus is in line with users' needs in Indonesia

Study Type

Interventional

Enrollment (Estimated)

150

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 Contact

Study Locations

  • Indonesia
      • Surabaya, Indonesia, 60115
        • Recruiting
        • Universitas Airlangga Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD
      • Surabaya, Indonesia, 60134
        • Completed
        • RSIA Kendangsari MERR 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 day to 2 weeks (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days

Exclusion Criteria:

- Infants transferred to the pediatric 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

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 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 of South-East Asian ethnicity and skin type.
Device: Picterus Jaundice Pro
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
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 Indonesian newborns
Time Frame: 6 months
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with TcB
Time Frame: 5-10 minutes
Correlate the estimates of bilirubin levels obtained by Picterus with TcB
5-10 minutes
Correlation with Tsb and TcB
Time Frame: 1-2 hours
Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB
1-2 hours
Picterus JP accuracy in Indonesian newborn
Time Frame: 6 months
Determine the accuracy of Picterus in Indonesian newborns
6 months

Collaborators and Investigators

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

Sponsor

Picterus AS

Collaborators

Airlangga University
RSIA Kendangsaru MERR Surabaya

Investigators

  • Study Director: Anders Aune, MD,MPH, Picterus AS

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)

December 12, 2022

Primary Completion (Estimated)

December 15, 2023

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/1608Indonesia2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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