A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates

The purpose of the study is to test the reliability of the Picterus smartphone application in Filipino neonates. A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application

Study Overview

• Status: Completed
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Device: Picterus Jaundice Pro

Detailed Description

The purpose of the study is to test the reliability of the Picterus smartphone application.

The study is designed for Filipino neonates, but implemented in other LMIC. The participants include newborns with or without jaundice, Gestational age >37 weeks, Age0-14days, Weight >2500 gram and absence of congenital malformations. Demographic data of the neonates will be collected together with all the performed tests and it will be stored in a secured system. Blood will be drawn and measure the bilirubin level of the neonates in a standard clinical routine and will be compared to the estimated bilirubin performed with the Picterus smartphone application.

A descriptive cross-sectional study will be the method to understand the correlation of the modalities and to determine the reliability of the application.

It will provide an answer to whether the Picterus smartphone application is reliable to other populations, especially to darker skin and with high melanin content such as Filipino neonates.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Philippines
  • Bohol
    • Tagbilaran City, Bohol, Philippines, 6300
      • Governor Celestino Gallares Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Newborns with or without jaundice
• Gestational age ≥ 37 weeks
• Age 0 - 14 days
• Weight 2500 to 4500 grams
• Absence of congenital malformations

Exclusion Criteria:

• Newborns with life-threatening conditions or significant illness

  • Newborns diagnosed with inborn errors of metabolism
  • Jaundiced newborns that have undergone phototherapy before screening

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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 with darker skin and with high melanin content such as Filipino neonates.	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
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates	Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.	5-10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates	correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates	1-2 hours
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.	correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.	5-10 minutes
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.	correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.	5 minutes
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.	sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.	5 months

Collaborators and Investigators

• Sponsor: Picterus AS
• Collaborators: Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing; Gov. Celestino Gallares Memorial Hospital
• Investigators: Study Director: Jon Øyvind Odland, Prof,MD,PhD, NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing

Publications and helpful links

Helpful Links

• Master thesis describing the study and its results

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): February 26, 2022
• Study Completion (Actual): February 26, 2022

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: 322016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No