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

NCT05616845 | Completed

• 1 other identifier: 322016
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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 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 those obtained using visual Kramer scale in Filipino neonates.

  5 minutes

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

  5 months

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Picterus Jaundice Pro

Interventions

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.

Also known as: Picterus JP

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

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns with or without jaundice
• Gestational age ≥ 37 weeks
• Age 0 - 14 days
• Weight 2500 to 4500 grams
• Absence of congenital malformations

You may not qualify if:

• Newborns with life-threatening conditions or significant illness
• Newborns diagnosed with inborn errors of metabolism
• Jaundiced newborns that have undergone phototherapy before screening

Sponsors & Collaborators

• Picterus AS: lead
• Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing: collaborator
• Gov. Celestino Gallares Memorial Hospital: collaborator

Study Sites (1)

Governor Celestino Gallares Memorial Hospital

Tagbilaran City, Bohol, 6300, Philippines

Location

Related Links

• Master thesis describing the study and its results

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Øyvind Odland, Prof,MD,PhD

  NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: February 2, 2022
• Primary Completion: February 26, 2022
• Study Completion: February 26, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

PH (1)