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

Not Applicable

Terminated

• Conditions: Jaundice, Neonatal
• Interventions: Device: Picterus Jaundice Pro

• Registration Number: NCT05623566
• Lead Sponsor: Picterus AS

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-11-29
• Primary Completion: 2018-11-29
• Study Completion: 2019-04-29
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-02
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 284

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enable high qualitative estimation of bilirubin levels in the blood of new-borns	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.

Primary Outcome Measures

Name	Time	Method
Enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.	5-10 minutes	Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in Indonesian newborns.

Secondary Outcome Measures

Name	Time	Method
correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns	5-10 minutes	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 in from a smartphone application and bilirubin measurements in serum in newborn	1-2 minutes	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 visual inspection in newborns	5-10 minutes	To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Trial Locations

Locations (3)

RSIA Kendangsari MERR; 🇮🇩 Surabaya, East Java, Indonesia

Dr. Soetomo General Hospital; 🇮🇩 Surabaya, East Java, Indonesia

Airlangga University hospital; 🇮🇩 Surabaya, East Java, Indonesia