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

Picterus

Status: Enrolling

Conditions: Jaundice, Neonatal

Treatments: Device: Picterus Jaundice Pro

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05630495

2018/1608Indonesia2022

Details and patient eligibility

About

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

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 1 to 14 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: Picterus Jaundice Pro