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

NCT05625880 | Completed

• 1 other identifier: 2018/1608Nepal
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  1-2 hours

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

  5-10 minutes

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

  5-10 minutes

Study Arms (1)

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

EXPERIMENTAL

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

Interventions

Picterus Jaundice Pro DEVICE

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

Also known as: Picterus JP

Enable high qualitative estimation of bilirubin levels in the blood of new-borns

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born with gestational age ≥35 weeks
• Birth weight ≥ 1750g
• Age 1 - ≤14 days
• Infants that will have a blood sample draw

You may not qualify if:

• Infants in the need for respiratory support
• Infants with conditions that could compromise skin circulation, as sepsis, heart failure
• Infants that have received phototherapy

Sponsors & Collaborators

• Picterus AS: lead
• St. Olavs Hospital: collaborator
• Dhulikhel Hospital: collaborator
• National Taiwan Normal University: collaborator

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, 45200, Nepal

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sunila Shakya, MD, PhD

  Dhulikhel Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief medical officer

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 23, 2022
• Study Start: June 1, 2019
• Primary Completion: June 28, 2019
• Study Completion: August 6, 2019
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

NE (1)