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NCT05623566 Clinical Trial

Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

Jaundice, Neonatal Clinical Trial

Official title:
Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05623566
Other study ID # 2018/1608Indonesia
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 29, 2018
Est. completion date April 29, 2019

Study information
Verified date April 2024
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns in Surabaya.

Description:

A cross-sectional conductive study aiming to evaluate the accuracy of a novel smartphone application that estimates bilirubin levels in newborns at Airlangga University hospital and RSIA Kendangsari MERR in Surabaya. This cross-sectional study evaluates the accuracy of a novel smartphone application that estimates bilirubin levels in Indonesian newborns. 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 Terminated
Enrollment 284
Est. completion date April 29, 2019
Est. primary completion date November 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Hour to 14 Days
Eligibility Inclusion Criteria: - Infants born with gestational age >31 - Birth weight = 1500g - Age 0 - =14 days - Consent obtained from the parents Exclusion Criteria: - Infants born with congenital abnormalities; - Infants respiratory support; - Infants suffering from a condition that may alter the skin tissue circulatory system, such as sepsis and heart failure; - Infants who have received phototherapy in the last 24 hours.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Picterus Jaundice Pro
In this study we aim to collect data of newborns with wider range of bilirubin levels to adjust the Picterus JP algorithm and optimize the app performance. This will enable a high qualitative estimation of bilirubin levels in the blood of new-borns for all skin colors.

Locations
Country Name City State
Indonesia Airlangga University hospital Surabaya East Java
Indonesia Dr. Soetomo General Hospital Surabaya East Java
Indonesia RSIA Kendangsari MERR Surabaya East Java

Sponsors (3)
Lead Sponsor Collaborator
Picterus AS RSIA Kendangsaru Surabaya, Universitas Airlangga

Country where clinical trial is conducted

Indonesia, 

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 Indonesian newborns. 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 minutes
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
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
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Completed NCT03570775 - Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice N/A
Completed NCT05625880 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Not yet recruiting NCT06449508 - The Effectiveness of Probiotics in Neonatal Jaundice Phase 1/Phase 2
Completed NCT05623553 - Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population N/A