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

Picterus

Status: Completed

Conditions: Jaundice, Neonatal

Treatments: Device: Picterus Jaundice Pro

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05616845

322016

Details and patient eligibility

About

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

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Experimental group

Description:

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.

Treatment:

Device: Picterus Jaundice Pro