Clincosm LogoSign in Get a demo

Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population

Sponsor
Picterus AS (Industry)
Overall Status
Completed
CT.gov ID
NCT05625880
Collaborator
St. Olavs Hospital (Other), Dhulikhel Hospital (Other), National Taiwan Normal University (Other)
200
Enrollment
1
Location
1
Arm
2.2
Actual Duration (Months)
92.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.

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

Detailed Description

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. 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 :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Jun 28, 2019
Actual Study Completion Date :
Aug 6, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Enable high qualitative estimation of bilirubin levels in the blood of new-borns

There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns using Picterus JP.

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 newborns, independent of skin color, using Picterus JP. [5-10 minutes]

      Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal.

    Secondary Outcome Measures

    1. correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn [1-2 hours]

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

    • Infants born with gestational age ≥35 weeks

    • Birth weight ≥ 1750g

    • Age 1 - ≤14 days

    • Infants that will have a blood sample draw

    Exclusion Criteria:

    • Infants in the need for respiratory support

    • Infants with conditions that could compromise skin circulation, as sepsis, heart failure

    • Infants that have received phototherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dhulikhel Hospital, Kathmandu University Hospital Dhulikhel Nepal 45200

    Sponsors and Collaborators

    • Picterus AS
    • St. Olavs Hospital
    • Dhulikhel Hospital
    • National Taiwan Normal University

    Investigators

    • Principal Investigator: Sunila Shakya, MD, PhD, Dhulikhel Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anders Aune, Chief medical officer, Picterus AS
    ClinicalTrials.gov Identifier:
    NCT05625880
    Other Study ID Numbers:
    • 2018/1608Nepal
    First Posted:
    Nov 23, 2022
    Last Update Posted:
    Nov 23, 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 23, 2022