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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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