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

Jaundice, Neonatal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630495
• Other study ID #: 2018/1608Indonesia2022
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: May 15, 2024

Study information

• Verified date: March 2023
• Source: Picterus AS
• Contact: Mahendra TA Sampurna, Dr, SP.A
• Phone: +62 031-5916290
• Email: mahendra.tri[@]fk.unair.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Jaundice
• Jaundice, Neonatal

Intervention

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.

Locations

Country	Name	City	State
Indonesia	RSIA Kendangsari MERR hospital	Surabaya
Indonesia	Universitas Airlangga Teaching Hospital	Surabaya

Sponsors (3)

Lead Sponsor	Collaborator
Picterus AS	Airlangga University, RSIA Kendangsaru MERR Surabaya

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation with TcB	Correlate the estimates of bilirubin levels obtained by Picterus with TcB	5-10 minutes
Secondary	Correlation with Tsb and TcB	Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB	1-2 hours
Secondary	Picterus JP accuracy in Indonesian newborn	Determine the accuracy of Picterus in Indonesian newborns	6 months