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

Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population at Dhulikhel Hospital, Kathmandu University Hospital.

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

Study Overview

• Status: Completed
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Device: Picterus Jaundice Pro

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Dhulikhel, Nepal, 45200
    • Dhulikhel Hospital, Kathmandu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enable high qualitative estimation of bilirubin levels in the blood of new-borns; 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.	Device: Picterus 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; Other Names: Picterus JP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5-10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	5-10 minutes

Collaborators and Investigators

• Sponsor: Picterus AS
• Collaborators: St. Olavs Hospital; National Taiwan Normal University; Dhulikhel Hospital
• Investigators: Principal Investigator: Sunila Shakya, MD, PhD, Dhulikhel Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: 2018/1608Nepal

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No