A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
Primary Purpose
Jaundice, Neonatal
Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
Picterus Jaundice Pro
Sponsored by
About this trial
This is an interventional screening trial for Jaundice, Neonatal
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
Sites / Locations
- Governor Celestino Gallares Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates
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.
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.
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 level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
Full Information
NCT ID
NCT05616845
First Posted
November 7, 2022
Last Updated
November 18, 2022
Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing, Gov. Celestino Gallares Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05616845
Brief Title
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
February 26, 2022 (Actual)
Study Completion Date
February 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Picterus AS
Collaborators
Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing, Gov. Celestino Gallares Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enable high qualitative estimation of bilirubin levels in the blood of new-borns
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Picterus Jaundice Pro
Other Intervention Name(s)
Picterus JP
Intervention Description
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Primary Outcome Measure Information:
Title
validate the reliability of the Picterus mHealth application as a screening tool for neonatal jaundice in Filipino neonates
Description
Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
Time Frame
5-10 minutes
Secondary Outcome Measure Information:
Title
correlation between the estimated levels of bilirubin detected by the Picterus mHealth application and bilirubin serum levels in Filipino neonates
Description
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
Title
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and transcutaneous bilirubinometer results in Filipino neonates.
Description
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
Title
correlation between the estimated level of bilirubin detected by the Picterus mHealth application and those obtained using visual Kramer scale in Filipino neonates.
Description
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
Title
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
Description
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Øyvind Odland, Prof,MD,PhD
Organizational Affiliation
NTNU Faculty of Medicine and Health Sciences, Department of Public Health and Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Governor Celestino Gallares Memorial Hospital
City
Tagbilaran City
State/Province
Bohol
ZIP/Postal Code
6300
Country
Philippines
12. IPD Sharing Statement
Links:
URL
https://ntnuopen.ntnu.no/ntnu-xmlui/handle/11250/3006144
Description
Master thesis describing the study and its results
Learn more about this trial
A mHealth Application as a Screening Tool for Neonatal Jaundice in Filipino Neonates
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