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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

Picterus Jaundice Pro

About this trial

This is an interventional screening trial for Jaundice, Neonatal

Eligibility Criteria

1 Day - 14 Days (Child)All SexesAccepts 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

Sites / Locations

Universitas Airlangga Teaching HospitalRecruiting
RSIA Kendangsari MERR hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Correlation with TcB

Correlate the estimates of bilirubin levels obtained by Picterus with TcB

Correlation with Tsb and TcB

Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB

Picterus JP accuracy in Indonesian newborn

Determine the accuracy of Picterus in Indonesian newborns

Full Information

NCT ID

NCT05630495

First Posted

November 8, 2022

Last Updated

July 13, 2023

Sponsor

Picterus AS

Collaborators

Airlangga University, RSIA Kendangsaru MERR Surabaya

1. Study Identification

Unique Protocol Identification Number

NCT05630495

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 12, 2022 (Actual)

Primary Completion Date

December 15, 2023 (Anticipated)

Study Completion Date

May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Picterus AS

Collaborators

Airlangga University, RSIA Kendangsaru MERR Surabaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Jaundice, Neonatal

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

Picterus Jaundice Pro

Other Intervention Name(s)

Picterus JP

Intervention Description

Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.

Primary Outcome Measure Information:

Title

Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns

Description

Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Correlation with TcB

Description

Correlate the estimates of bilirubin levels obtained by Picterus with TcB

Time Frame

5-10 minutes

Title

Correlation with Tsb and TcB

Description

Correlate the estimates of bilirubin levels obtained by Picterus with TSB and TcB

Time Frame

1-2 hours

Title

Picterus JP accuracy in Indonesian newborn

Description

Determine the accuracy of Picterus in Indonesian newborns

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mahendra TA Sampurna, Dr, SP.A

Phone

+62 031-5916290

Email

mahendra.tri@fk.unair.ac.id

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Aune, MD,MPH

Organizational Affiliation

Picterus AS

Official's Role

Study Director

Facility Information:

Facility Name

Universitas Airlangga Teaching Hospital

City

Surabaya

ZIP/Postal Code

60115

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

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

Email

mahendra.tri@fk.unair.ac.id

First Name & Middle Initial & Last Name & Degree

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

Facility Name

RSIA Kendangsari MERR hospital

City

Surabaya

ZIP/Postal Code

60134

Country

Indonesia

Individual Site Status

Completed

12. IPD Sharing Statement

Plan to Share IPD

No

Jaundice, Neonatal

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial