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NCT05625880 Clinical Trial

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

Jaundice, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05625880
Other study ID # 2018/1608Nepal
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date August 6, 2019

Study information
Verified date November 2022
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 6, 2019
Est. primary completion date June 28, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 14 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
Nepal Dhulikhel Hospital, Kathmandu University Hospital Dhulikhel

Sponsors (4)
Lead Sponsor Collaborator
Picterus AS Dhulikhel Hospital, National Taiwan Normal University, St. Olavs Hospital

Country where clinical trial is conducted

Nepal, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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 1-2 hours
Secondary 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 5-10 minutes
Secondary 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 5-10 minutes
See also
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Completed NCT05650463 - Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns N/A
Terminated NCT05623566 - Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia N/A
Completed NCT02612727 - Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates N/A
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Completed NCT03184948 - Understanding Neonatal Jaundice in Rwanda N/A
Completed NCT03942757 - BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
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Completed NCT03569254 - Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Completed NCT05623553 - Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population N/A
Completed NCT03007563 - Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice N/A