Clinical Trials Logo
  1. Home
  2. Jaundice, Neonatal
  3. NCT05650463
  4. Details
NCT05650463 Clinical Trial

Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns

Jaundice, Neonatal Clinical Trial

Official title:
Evaluation of a Smartphone-based Screening Tool (Picterus Jaundice Pro) for Neonatal Jaundice in Dark Skin Newborns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05650463
Other study ID # Stockholm
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 29, 2021
Est. completion date August 31, 2022

Study information
Verified date December 2022
Source Picterus AS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A cross-sectional study at the Södersjukehuset facility (Stockholm, Sweden) collect data of newborns from a population with Neomar scale type 4 to adjust the algorithm of Picterus JP

Description:

To adjust Picterus JP to work in newborns with more pigmented skin, the investigators will collect a data set at Sachsska barnsjukhuset Södersjukhuset, Stockholm Sweden from 150 newborns with dark skins using Picterus JP, TcB, skin measurements from a spectrometer, visual assessment, and total serum bilirubin (TSB) levels. As a control, newborns with Neomar scale 1-3 will be included.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date August 31, 2022
Est. primary completion date November 29, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 14 Days
Eligibility Inclusion Criteria: - Infants born with gestational age = 37 - Birth weight = 2500g - Age 1 - 14 days - Will have a blood sample performed, either for clinically suspected jaundice or newborn screening sample Exclusion Criteria: - Infants showing signs of inborn disease - Infants transferred to pediatric ward for treatment - Infants that have received phototherapy

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
Sweden Södersjukhuset Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Picterus AS Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Enable high qualitative estimation of bilirubin levels in newborns, independent of skin color, using Picterus JP Evaluate of smartphone-based screening tool (Picterus JP) for neonatal jaundice in newborns with Neomar neonatal skin color scale type 4 (with type 1 being lower-melanin level and Type 4 being higher-melanin level) 6 months
Secondary Comparison of Picterus-generated estimate with TsB Compare bilirubin estimates calculated with the adjusted algoritm from the images with TSB measurements 1-2 hours
Secondary Comparison of Picterus-generated estimate with TcB Compare bilirubin estimates calculated with the adjusted algoritm from the images with TcB measurements 5-10min
Secondary Comparison of Picterus-generated estimate with visual assessment. Compare bilirubin estimates calculated with the adjusted algoritm from the images with visual assessment. 5-10min
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
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
Completed NCT05623553 - Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population N/A