Validation of an Innovative Neonatal Jaundice Detection System (Picterus) in Indonesia

The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:

• Demonstrate that Picterus system performs accurately in Indonesian newborns
• Ensure that Picterus is in line with users' needs in Indonesia

Study Overview

• Status: Recruiting
• Conditions: Jaundice, Neonatal
• Intervention / Treatment: Device: Picterus Jaundice Pro

Detailed Description

The long-term goal of this project is to establish Picterus as a permanent tool to detect NNJ in the healthcare services of Indonesia. Offering early detection and therefore, timely treatment to NNJ, will substantially improve neonatal health and directly work towards the Sustainable Development Goal 3.2.2, reduce neonatal mortality. The study as the following specific subgoals:

• Demonstrate that Picterus system performs accurately in Indonesian newborns
• Ensure that Picterus is in line with users' needs in Indonesia

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahendra TA Sampurna, Dr, SP.A; Phone Number: +62 031-5916290; Email: mahendra.tri@fk.unair.ac.id

Study Locations

• Indonesia
  • Surabaya, Indonesia, 60115
    • Recruiting
    • Universitas Airlangga Teaching Hospital
    • Contact: Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD; Email: mahendra.tri@fk.unair.ac.id
    • Principal Investigator: Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD
  • Surabaya, Indonesia, 60134
    • Completed
    • RSIA Kendangsari MERR hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 weeks (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- Infants born with gestational age ≥37 weeks Birth weight ≥2000g and ≤4500g Age 1 - 14 days

Exclusion Criteria:

- Infants transferred to the pediatric ward for advanced treatment. Infants with a skin rash or other disease that affects the skin where measurements are performed.

Infants that receive or have received phototherapy in the last 24 hours. Infants with an inborn disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enable high qualitative estimation of bilirubin levels in the blood of new-borns; In this study we aim to collect data of newborns with wider range of bilirubin levels and additionally measurements of skin color reflectance with a spectrophotometer, 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 of South-East Asian ethnicity and skin type.

Device: Picterus Jaundice Pro; Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.; Other Names: Picterus JP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns	Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation with TcB	Correlate the estimates of bilirubin levels obtained by Picterus with TcB	5-10 minutes
Correlation with Tsb and TcB	Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB	1-2 hours
Picterus JP accuracy in Indonesian newborn	Determine the accuracy of Picterus in Indonesian newborns	6 months

Collaborators and Investigators

• Sponsor: Picterus AS
• Collaborators: Airlangga University; RSIA Kendangsaru MERR Surabaya
• Investigators: Study Director: Anders Aune, MD,MPH, Picterus AS

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): May 15, 2024

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice; Jaundice, Neonatal
• Other Study ID Numbers: 2018/1608Indonesia2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No