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

Sponsor
Picterus AS (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05630495
Collaborator
Airlangga University (Other), RSIA Kendangsaru MERR Surabaya (Other)
150
Enrollment
1
Arm
1.5
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Picterus Jaundice Pro
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia
Anticipated Study Start Date :
Nov 30, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Jan 15, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns [6 months]

      Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.

    Secondary Outcome Measures

    1. Correlation with TcB [5-10 minutes]

      Correlate the estimates of bilirubin levels obtained by Picterus with TcB

    2. Correlation with Tsb and TcB [1-2 hours]

      Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB

    3. Picterus JP accuracy in Indonesian newborn [6 months]

      Determine the accuracy of Picterus in Indonesian newborns

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 14 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Picterus AS
    • Airlangga University
    • RSIA Kendangsaru MERR Surabaya

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Picterus AS
    ClinicalTrials.gov Identifier:
    NCT05630495
    Other Study ID Numbers:
    • 2018/1608Indonesia2022
    First Posted:
    Nov 29, 2022
    Last Update Posted:
    Nov 29, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Jaundice, Neonatal
    Jaundice

    Study Results

    No Results Posted as of Nov 29, 2022