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

Not Applicable

Completed

• Conditions: Jaundice, Neonatal
• Interventions: Device: Picterus Jaundice Pro

• Registration Number: NCT05616845
• Lead Sponsor: Picterus AS

Brief 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

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 Timeline

• Study Start: 2022-02-02
• Primary Completion: 2022-02-26
• Study Completion: 2022-02-26
• Status Verified: 2022-11
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-15
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enable high qualitative estimation of bilirubin levels in the blood of new-borns	Picterus Jaundice Pro	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.

Primary Outcome Measures

Name	Time	Method
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates	5-10 minutes	Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.

Secondary Outcome Measures

Name	Time	Method
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	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 levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates	1-2 hours	correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels 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 transcutaneous bilirubinometer results in Filipino neonates.
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.	5 months	sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.

Trial Locations

Locations (1)

Governor Celestino Gallares Memorial Hospital; 🇵🇭 Tagbilaran City, Bohol, Philippines