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

Not Applicable

Completed

• Conditions: Jaundice, Neonatal
• Interventions: Device: Picterus Jaundice Pro

• Registration Number: NCT05625880
• Lead Sponsor: Picterus AS

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-06-28
• Study Completion: 2019-08-06
• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-18
• Last Update Submitted: 2022-11-18
• Study First Posted: 2022-11-23
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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 using Picterus JP.

Primary Outcome Measures

Name	Time	Method
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.	5-10 minutes	Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal.

Secondary Outcome Measures

Name	Time	Method
correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn	1-2 hours	To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns	5-10 minutes	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
Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns	5-10 minutes	To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Trial Locations

Locations (1)

Dhulikhel Hospital, Kathmandu University Hospital; 🇳🇵 Dhulikhel, Nepal