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

Jaundice, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616845
• Other study ID #: 322016
• Status: Completed
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: February 26, 2022

Study information

• Verified date: November 2022
• Source: Picterus AS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 26, 2022
• Est. primary completion date: February 26, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal

Intervention

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.

Locations

Country	Name	City	State
Philippines	Governor Celestino Gallares Memorial Hospital	Tagbilaran City	Bohol

Sponsors (3)

Lead Sponsor	Collaborator
Picterus AS	Gov. Celestino Gallares Memorial Hospital, Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Master thesis describing the study and its results