Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05630495
Other study ID # 2018/1608Indonesia2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00735319 - Transcutaneous Bilirubinometers in the Community N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Withdrawn NCT04021927 - Development of a Neonatal Jaundice Treatment Accelerator by Redirection of Unused Light During Phototherapy N/A
Completed NCT01887327 - Stannsoporfin With Light Therapy for Newborn Babies With Jaundice Phase 2
Completed NCT04632888 - The Effect of Telephone Support for Breastfeeding Follow-up on Infantile Colic and Maternal Breastfeeding Self-efficacy N/A
Not yet recruiting NCT04527536 - Research of Diagnostic Value for BMJ Infants
Suspended NCT03741803 - Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice N/A
Completed NCT05650463 - Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns N/A
Terminated NCT05623566 - Evaluation of a Smartphone Based Screening Tool for Neonatal Jaundice in Surabaya, Indonesia N/A
Completed NCT02612727 - Filtered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates N/A
Completed NCT01434810 - Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates N/A
Completed NCT03184948 - Understanding Neonatal Jaundice in Rwanda N/A
Completed NCT03942757 - BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed NCT06372093 - Evaluation of Bilirubin Measurements in Newborns From Smartphone Digital Images in a Population in Botswana N/A
Completed NCT03570775 - Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice N/A
Completed NCT03569254 - Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice N/A
Completed NCT05625880 - Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Nepali Population N/A
Completed NCT01169740 - Transcutaneous Measurement of Jaundice in the Newborn N/A
Not yet recruiting NCT06449508 - The Effectiveness of Probiotics in Neonatal Jaundice Phase 1/Phase 2