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OpenTrials
Completed

NCT Number: NCT05616845

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

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Key information

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Governor Celestino Gallares Memorial Hospital

Tagbilaran City, Bohol, 6300, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Picterus Jaundice Pro

Device

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

Primary outcomes

  1. validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates

    Time frame: 5-10 minutes

    Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.

Secondary outcomes

  1. correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates

    Time frame: 1-2 hours

    correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates

  2. correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.

    Time frame: 5-10 minutes

    correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.

  3. correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.

    Time frame: 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.

  4. sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.

    Time frame: 5 months

    sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.

Sponsors and collaborators

Lead sponsor

Picterus AS

Industry

Collaborators

  • Gov. Celestino Gallares Memorial Hospital
  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2022
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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