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

NCT ID: NCT05625880

Last Updated: 2022-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2019-08-06

Brief Summary

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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

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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.

Conditions

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Jaundice, Neonatal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Picterus Jaundice Pro

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Picterus JP

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role collaborator

Dhulikhel Hospital

OTHER

Sponsor Role collaborator

National Taiwan Normal University

OTHER

Sponsor Role collaborator

Picterus AS

INDUSTRY

Sponsor Role lead

Responsible Party

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Anders Aune

Chief medical officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sunila Shakya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dhulikhel Hospital

Locations

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Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, , Nepal

Site Status

Countries

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Nepal

Other Identifiers

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2018/1608Nepal

Identifier Type: -

Identifier Source: org_study_id

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