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

Primary Purpose

Jaundice, Neonatal

Status

Completed

Phase

Not Applicable

Locations

Nepal

Study Type

Interventional

Intervention

Picterus Jaundice Pro

About this trial

This is an interventional screening trial for Jaundice, Neonatal

Eligibility Criteria

1 Day - 14 Days (Child)All SexesAccepts 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

Sites / Locations

Dhulikhel Hospital, Kathmandu University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

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

Full Information

NCT ID

NCT05625880

First Posted

November 10, 2022

Last Updated

November 18, 2022

Sponsor

Picterus AS

Collaborators

St. Olavs Hospital, Dhulikhel Hospital, National Taiwan Normal University

1. Study Identification

Unique Protocol Identification Number

NCT05625880

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

June 1, 2019 (Actual)

Primary Completion Date

June 28, 2019 (Actual)

Study Completion Date

August 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Picterus AS

Collaborators

St. Olavs Hospital, Dhulikhel Hospital, National Taiwan Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaundice, Neonatal

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Picterus Jaundice Pro

Other Intervention Name(s)

Picterus JP

Intervention Description

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

Primary Outcome Measure Information:

Title

Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

Description

Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns at Dhulikhel Hospital, Kathmandu Nepal.

Time Frame

5-10 minutes

Secondary Outcome Measure Information:

Title

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

Description

To evaluate the correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborns with varying degree of jaundice

Time Frame

1-2 hours

Title

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

Description

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

Time Frame

5-10 minutes

Title

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

Description

To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Time Frame

5-10 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sunila Shakya, MD, PhD

Organizational Affiliation

Dhulikhel Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dhulikhel Hospital, Kathmandu University Hospital

City

Dhulikhel

ZIP/Postal Code

45200

Country

Nepal

12. IPD Sharing Statement

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

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