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

NCT05630495 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-07-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Airlangga University

    collaborator UNKNOWN

  • RSIA Kendangsaru MERR Surabaya

    collaborator UNKNOWN

  • Picterus AS

    lead INDUSTRY

Principal Investigators

  • Anders Aune, MD,MPH · Picterus AS

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2023-12-15
Completion
2024-05-15

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05630495 on ClinicalTrials.gov