Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
- Conditions
- Jaundice, Neonatal
- Interventions
- Device: Picterus Jaundice Pro
- Registration Number
- NCT05623553
- Lead Sponsor
- Picterus AS
- Brief Summary
This corss-sectional study aims to test the performance and accuracy of the Picterus JP screening device in newborns with different skin types.
- Detailed Description
A descriptive cross-sectional study among 174 newborns was carried out at Hospital Materno-Infantil de Irapuato in Mexico during July and August 2018.
The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. A validated smartphone with Picterus JP will be used to collect digital images..
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
- Healthy newborns with or without signs of jaundice
- Gestational age >35 weeks
- Age 0-14 days
- Birth weight > 1500 g.
- Parents acceptance of their children to participate in the study.
- Newborn needing a blood test
- Newborns showing signs or with diagnosis of inborn diseases
- Newborn transferred to pediatric ward for any treatment
- Newborns who had received phototherapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Enable high qualitative estimation of bilirubin levels in the blood of new-borns Picterus Jaundice Pro There is only one arm in this study which is to enable high qualitative estimation of bilirubin levels in the blood of new-borns, independent of skin color, using Picterus JP.
- Primary Outcome Measures
Name Time Method Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP 6 months Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns.
- Secondary Outcome Measures
Name Time Method Correlation with visual assessment 5-10 minutes Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using visual Kramer scale in a population of Mexican neonates.
Correlation with TsB 1-2 hours Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with bilirubin serum levels in a population of Mexican neonates.
Correlation with TcB 5-10 minutes Demonstrate the correlation among the estimated levels of bilirubin obtained through a smartphone based diagnostic tool with those obtained using a transcutaneous bilirubinometer in a population of Mexican neonates.
Trial Locations
- Locations (1)
Hospital Materno- Infantil de Irapuato
🇲🇽Irapuato, Guanajuato, Mexico