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

NCT ID: NCT05630495

Last Updated: 2023-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2024-05-15

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

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

Conditions

Jaundice, Neonatal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Picterus Jaundice Pro

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Picterus JP

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Airlangga University

UNKNOWN

Sponsor Role: collaborator

RSIA Kendangsaru MERR Surabaya

UNKNOWN

Sponsor Role: collaborator

Picterus AS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Aune, MD,MPH

Role: STUDY_DIRECTOR

Picterus AS

Locations

Universitas Airlangga Teaching Hospital

Surabaya, , Indonesia

Site Status: RECRUITING

RSIA Kendangsari MERR hospital

Surabaya, , Indonesia

Site Status: COMPLETED

Countries

Indonesia

Central Contacts

Mahendra TA Sampurna, Dr, SP.A

Role: CONTACT

mahendra.tri@fk.unair.ac.id

+62 031-5916290

Facility Contacts

Mahendra Tri Arif Sampurna, dr., Sp.A(K), PhD

Role: primary

mahendra.tri@fk.unair.ac.id

Other Identifiers

2018/1608Indonesia2022

Identifier Type: -

Identifier Source: org_study_id