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

NCT05630495 | Unknown

• 1 other identifier: 2018/1608Indonesia2022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Jaundice, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation with TcB

  5-10 minutes

• Correlation with Tsb and TcB

  1-2 hours

• Picterus JP accuracy in Indonesian newborn

  6 months

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 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

Interventions

Picterus Jaundice Pro DEVICE

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Also known as: Picterus JP

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

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \- 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

Sponsors & Collaborators

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

Study Sites (2)

Universitas Airlangga Teaching Hospital

Surabaya, 60115, Indonesia

RECRUITING

RSIA Kendangsari MERR hospital

Surabaya, 60134, Indonesia

COMPLETED

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 Officials

• Anders Aune, MD,MPH

  Picterus AS

  STUDY DIRECTOR

Central Study Contacts

Mahendra TA Sampurna, Dr, SP.A

CONTACT

+62 031-5916290; mahendra.tri@fk.unair.ac.id

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 8, 2022
• First Posted: November 29, 2022
• Study Start: December 12, 2022
• Primary Completion: December 15, 2023
• Study Completion: May 15, 2024
• Last Updated: July 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)