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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05630495
Enrollment
150
Registered
2022-11-29
Start date
2022-12-12
Completion date
2024-05-15
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal

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

Interventions

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

Universitas Airlangga
CollaboratorOTHER
RSIA Kendangsaru MERR Surabaya
CollaboratorUNKNOWN
Picterus AS
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 14 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Enable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns6 monthsEnable high qualitative estimation of bilirubin levels in the blood of Indonesian newborns using Picterus JP.

Secondary

MeasureTime frameDescription
Correlation with TcB5-10 minutesCorrelate the estimates of bilirubin levels obtained by Picterus with TcB
Correlation with Tsb and TcB1-2 hoursCorrelate the estimates of bilirubin levels obtained by Picterus with TSB and TcB
Picterus JP accuracy in Indonesian newborn6 monthsDetermine the accuracy of Picterus in Indonesian newborns

Countries

Indonesia

Contacts

Primary ContactMahendra TA Sampurna, Dr, SP.A
mahendra.tri@fk.unair.ac.id+62 031-5916290

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026