Clinical trial NCT05616845: A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
Official title: A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Lead sponsor: Picterus AS
Sponsor class: INDUSTRY
Collaborators: name: Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing
name: Gov. Celestino Gallares Memorial Hospital
First posted: 2022-11-15
Enrollment: 69
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates
timeFrame: 5-10 minutes
Secondary outcomes:
measure: correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates
timeFrame: 1-2 hours
measure: correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.
timeFrame: 5-10 minutes
measure: correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.
timeFrame: 5 minutes
measure: sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
timeFrame: 5 months
Other outcomes:
Locations:
city: Tagbilaran City
country: Philippines
facility: Governor Celestino Gallares Memorial Hospital
state: Bohol
Study officials:
affiliation: NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
name: Jon Øyvind Odland, Prof,MD,PhD
role: STUDY_DIRECTOR
References: