NCT05955144

Brief Summary

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

July 13, 2023

Last Update Submit

July 13, 2023

Conditions

Neonatal Jaundice

Outcome Measures

Primary Outcomes (1)

  • jaundice screening

    reproducible jaundice screening independent of smartphone used

    6 months

Study Arms (1)

Repeatable bilirubin measurement independent of phone

OTHER

all subjects will receive bilirubin measurement from 4 different smartphones and a transcutaneous device to ensure that the measurement of bilirubin is not affected by phone camera

Device: Picterus JP

Interventions

Picterus JPDEVICE

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

Repeatable bilirubin measurement independent of phone

Eligibility Criteria

Age1 Day - 14 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants born with gestational age \> 37 weeks.
  • Birth weight ≥ 2500 grams
  • Age 1 - 14 days

You may not qualify if:

  • Infants showing signs of inborn disease.
  • Infants with skin rash or other skin disease that affects the skin where measurements are performed.
  • Infants transferred to the pediatric ward for medical treatment.
  • Infants that have received phototherapy in the last 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olav Hospital

Trondheim, 7006, Norway

RECRUITING

MeSH Terms

Conditions

Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, NeonatalInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperbilirubinemiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Deborah Hill

CONTACT

45188628deborah@picterus.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2023

First Posted

July 21, 2023

Study Start

October 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 1, 2024

Last Updated

July 21, 2023

Record last verified: 2023-07

Locations

NO(1)