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

Not Applicable

Recruiting

• Conditions: Jaundice, Neonatal

• Registration Number: NCT05630495
• Lead Sponsor: Picterus AS

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

Study Timeline

• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-18
• Study First Posted: 2022-11-29
• Study Start: 2022-12-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-14
• Primary Completion: 2023-12-15
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns	6 months	Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Universitas Airlangga Teaching Hospital; 🇮🇩 Surabaya, Indonesia

RSIA Kendangsari MERR hospital; 🇮🇩 Surabaya, Indonesia