NCT05623553
Completed
Not Applicable
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
ConditionsJaundice, Neonatal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Jaundice, Neonatal
- Sponsor
- Picterus AS
- Enrollment
- 174
- Locations
- 1
- Primary Endpoint
- Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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..
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Enable high qualitative estimation of bilirubin levels in the blood of newborns using Picterus JP
Time Frame: 6 months
Evaluate of smartphone-based diagnostic tool (Picterus JP) for neonatal jaundice in newborns.
Secondary Outcomes
- Correlation with visual assessment(5-10 minutes)
- Correlation with TsB(1-2 hours)
- Correlation with TcB(5-10 minutes)
Study Sites (1)
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