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NCT05616845 Clinical Trial

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

Jaundice, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05616845
Other study ID # 322016
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2022
Est. completion date February 26, 2022

Study information
Verified date November 2022
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date February 26, 2022
Est. primary completion date February 26, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 14 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Picterus Jaundice Pro
Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Locations
Country Name City State
Philippines Governor Celestino Gallares Memorial Hospital Tagbilaran City Bohol

Sponsors (3)
Lead Sponsor Collaborator
Picterus AS Gov. Celestino Gallares Memorial Hospital, Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 1-2 hours
Secondary 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. 5-10 minutes
Secondary 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. 5 minutes
Secondary 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. 5 months
See also
  Status Clinical Trial Phase
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Completed NCT01887327 - Stannsoporfin With Light Therapy for Newborn Babies With Jaundice Phase 2
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Completed NCT05650463 - Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns N/A
Terminated NCT05623566 - Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia N/A
Completed NCT02612727 - Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates N/A
Completed NCT01434810 - Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates N/A
Completed NCT03184948 - Understanding Neonatal Jaundice in Rwanda N/A
Completed NCT03942757 - BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed NCT06372093 - Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Completed NCT03569254 - Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice N/A
Completed NCT03570775 - Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice N/A
Completed NCT05625880 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Completed NCT05623553 - Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population N/A

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