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

Picterus

Status: Completed

Conditions: Jaundice, Neonatal

Treatments: Device: Picterus Jaundice Pro

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05625880

2018/1608Nepal

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Picterus Jaundice Pro