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

Sponsor
Picterus AS (Industry)
Overall Status
Completed
CT.gov ID
NCT05623566
Collaborator
Airlangga University (Other), RSIA Kendangsaru MERR Surabaya (Other)
284
Enrollment
3
Locations
1
Arm
5
Actual Duration (Months)
94.7
Patients Per Site
19.1
Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:
Interventional
Actual Enrollment :
284 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia
Actual Study Start Date :
Nov 29, 2018
Actual Primary Completion Date :
Nov 29, 2018
Actual Study Completion Date :
Apr 29, 2019

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 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP. [5-10 minutes]

      Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.

    Secondary Outcome Measures

    1. Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn [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

    2. correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns [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

    3. Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Days to 14 Days
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Airlangga University hospital Surabaya East Java Indonesia 60115
    2 RSIA Kendangsari MERR Surabaya East Java Indonesia 60134
    3 Dr. Soetomo General Hospital Surabaya East Java Indonesia 60286

    Sponsors and Collaborators

    • Picterus AS
    • Airlangga University
    • RSIA Kendangsaru MERR Surabaya

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Picterus AS
    ClinicalTrials.gov Identifier:
    NCT05623566
    Other Study ID Numbers:
    • 2018/1608Indonesia
    First Posted:
    Nov 21, 2022
    Last Update Posted:
    Nov 21, 2022
    Last Verified:
    Nov 1, 2022
    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 21, 2022