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

NCT05623566 | Terminated

• 1 other identifier: 2018/1608Indonesia
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 3

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.

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation between bilirubin estimates in from a smartphone application and bilirubin measurements in serum in newborn

  1-2 minutes

• correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns

  5-10 minutes

• Correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns

  5-10 minutes

Study Arms (1)

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

EXPERIMENTAL

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.

Device: Picterus Jaundice Pro

Interventions

Picterus Jaundice Pro DEVICE

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.

Also known as: Picterus JP

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

Eligibility Criteria

• Age: 1 Hour - 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born with gestational age \>31
• Birth weight ≥ 1500g
• Age 0 - ≤14 days
• Consent obtained from the parents

You may not qualify if:

• 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.

Sponsors & Collaborators

• Picterus AS: lead
• RSIA Kendangsaru Surabaya: collaborator
• Universitas Airlangga: collaborator

Study Sites (3)

Airlangga University hospital

Surabaya, East Java, 60115, Indonesia

Location

RSIA Kendangsari MERR

Surabaya, East Java, 60134, Indonesia

Location

Dr. Soetomo General Hospital

Surabaya, East Java, 60286, Indonesia

Location

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 21, 2022
• Study Start: November 29, 2018
• Primary Completion: November 29, 2018
• Study Completion: April 29, 2019
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

ID (3)