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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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05625880
Enrollment
200
Registered
2022-11-23
Start date
2019-06-01
Completion date
2019-08-06
Last updated
2022-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal

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.

Interventions

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

Sponsors

St. Olavs Hospital
CollaboratorOTHER
Dhulikhel Hospital
CollaboratorOTHER
National Taiwan Normal University
CollaboratorOTHER
Picterus AS
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn1-2 hoursTo 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 newborns5-10 minutesTo 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 newborns5-10 minutesTo evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026