Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population

Picterus AS200 enrolled

Overview

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Dhulikhel Hospital, Kathmandu Nepal.

This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in 200 newborns at Dhulikhel Hospital, Kathmandu Nepal. The Picterus Calibration Card was 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 was used to collect digital images.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

Jaundice, Neonatal

Interventions

Picterus Jaundice ProDEVICE

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

Eligibility

Sex: ALLMin age: 1 DayMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Infants born with gestational age ≥35 weeks * Birth weight ≥ 1750g * Age 1 - ≤14 days * Infants that will have a blood sample draw Exclusion Criteria: * Infants in the need for respiratory support * Infants with conditions that could compromise skin circulation, as sepsis, heart failure * Infants that have received phototherapy

Locations (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Nepal

Outcomes

Primary Outcomes

Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal.

Time frame: 5-10 minutes

Secondary Outcomes

correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn

To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice

Time frame: 1-2 hours

correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice

Time frame: 5-10 minutes

Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Time frame: 5-10 minutes

Data from ClinicalTrials.gov

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