Jaundice, Neonatal
Conditions
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..
Interventions
DEVICEPicterus 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.
Sponsors
Norwegian University of Science and Technology Faculty of Medicine and Health Sciences Department of Public Health and Nursing
Hospital Materno- Infantil de Irapuato
Picterus AS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Newborns showing signs or with diagnosis of inborn diseases * Newborn transferred to pediatric ward for any treatment * Newborns who had received phototherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Mexico
Outcome results
None listed