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

Picterus

Status: Terminated

Conditions: Jaundice, Neonatal

Treatments: Device: Picterus Jaundice Pro

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05623566

2018/1608Indonesia

Details and patient eligibility

About

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

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 1 hour to 14 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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284 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Picterus Jaundice Pro