Governor Celestino Gallares Memorial Hospital
Tagbilaran City, Bohol, 6300, Philippines
NCT Number: NCT05616845
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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All sexes
Interventional
Not applicable
Tagbilaran City, Bohol, 6300, Philippines
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 5-10 minutes
Validation of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with high melanin content.
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
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.
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.
Time frame: 5 months
sensitivity, specificity, positive and negative predictive value between estimated bilirubin level of the digital images, Kramer examination and TcB.
Picterus AS
Industry
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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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