Identification of Jaundice in Newborns Using Smartphones
Primary Purpose
Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bilirubin estimates from Smartphone Application
Bilirubin concentration measured in standard blood samples
Bilirubin estimates from standard transcutaneous device
Visual assessment of jaundice
Sponsored by
About this trial
This is an interventional screening trial for Jaundice, Neonatal focused on measuring Diagnosis, Cell Phones, Infant, Newborn, Skin Pigmentation
Eligibility Criteria
Inclusion Criteria:
- Born in St.Olavs hospital, Trondheim or in Haugesund Hospital, Norway
- Born with gestational age >36+6
- Birth weight ≥ 2500g and <4500g
- Age 1 - <15 days
- Are having a blood sample performed, as newborn screening or for jaundice assessment
Exclusion criteria:
Infants needing intensive treatment. This includes:
- Infants in the need for respiratory support
- Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other
- Infants that have received phototherapy
Sites / Locations
- Haugesund Hospital
- St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Newborns in St.Olavs Hospital and Haugesund Hospital
Arm Description
All newborns will be examined through 4 different methods of determining jaundice.
Outcomes
Primary Outcome Measures
Smartphone application sensitivity
Sensitivity of the smartphone application to detect severe jaundice, defined as total serum bilirubin value > 250 umol/l.
Secondary Outcome Measures
Repeatability
To evaluate the repeatability of multiple measurements with the new smartphone tool
Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin
Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements in total serum. Correlation will be expressed by Pearson correlation coefficient, r.
Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice. Correlation will be expressed by Pearson correlation coefficient, r.
Correlation between bilirubin estimates by smartphone pictures and visual assessment of jaundice
- To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
Full Information
NCT ID
NCT04182555
First Posted
November 27, 2019
Last Updated
September 22, 2022
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Fonna
1. Study Identification
Unique Protocol Identification Number
NCT04182555
Brief Title
Identification of Jaundice in Newborns Using Smartphones
Official Title
Identification of Jaundice in Newborns Using Smartphones
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology, Helse Fonna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world. The treatment of jaundice, phototherapy, is in most cases easy, low-cost and harmless. The crucial point in reducing the burden of disease is therefore to identify then children at risk. This results in the need for low-cost, reliable and easy-to-use diagnostic tools that can identify newborns with jaundice.
Based on previous research on the bio-optics of jaundiced newborn skin, a prototype of a smartphone application was developed and tested in a pilot study and the application refined.
This smartphone application will now be evaluated in a clinical trial set in two hospitals in Norway. The smartphone application gives immediate estimates of bilirubin values in newborns, and these estimates will be compared to the bilirubin levels measured in standard blood samples, as well as the results from ordinary transcutaneous measurement devices.
Detailed Description
The smartphone jaundice app system works by taking pictures of newborns with a custom-made color calibration card placed on their chest. This makes it possible to measure the skin color precisely regardless of the specific light source that is used to illuminate the newborn. The measured skin color is then compared with items in a database of simulated newborn skin colors. These simulated newborn skin colors have been created using numerical simulations of how light moves through skin, with varying skin parameters including, but not limited to, skin thickness, blood concentration, melanin, and of course bilirubin, the pigment that causes jaundice. By comparing the measured skin color with the simulated skin colors that are most similar to it, the investigators can then estimate the bilirubin concentration in the newborn's skin by e.g. averaging the bilirubin concentrations used to create these simulated skin colors.
In a group of 200 newborns with varying degree of jaundice, correlation between smartphone bilirubin estimates will be compared with total serum bilirubin and standard transcutaneous bilirubinometry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
Keywords
Diagnosis, Cell Phones, Infant, Newborn, Skin Pigmentation
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
200 newborns with varying degree of jaundice will be recruited.
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Newborns in St.Olavs Hospital and Haugesund Hospital
Arm Type
Experimental
Arm Description
All newborns will be examined through 4 different methods of determining jaundice.
Intervention Type
Device
Intervention Name(s)
Bilirubin estimates from Smartphone Application
Intervention Description
Bilirubin estimates through color analysis of digital images obtained through smartphone application.
Intervention Type
Diagnostic Test
Intervention Name(s)
Bilirubin concentration measured in standard blood samples
Intervention Description
Bilirubin measured in total serum bilirubin.
Intervention Type
Device
Intervention Name(s)
Bilirubin estimates from standard transcutaneous device
Intervention Description
Bilirubin estimates performed by transcutaneous device ( Dräger JM-105)
Intervention Type
Other
Intervention Name(s)
Visual assessment of jaundice
Intervention Description
Degree of jaundice will be assessed by Kramer scale
Primary Outcome Measure Information:
Title
Smartphone application sensitivity
Description
Sensitivity of the smartphone application to detect severe jaundice, defined as total serum bilirubin value > 250 umol/l.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Repeatability
Description
To evaluate the repeatability of multiple measurements with the new smartphone tool
Time Frame
5 min
Title
Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin
Description
Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements in total serum. Correlation will be expressed by Pearson correlation coefficient, r.
Time Frame
5 minutes
Title
Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.
Description
To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from a standard transcutaneous device in newborns with varying degree of jaundice. Correlation will be expressed by Pearson correlation coefficient, r.
Time Frame
5 minutes
Title
Correlation between bilirubin estimates by smartphone pictures and visual assessment of jaundice
Description
- To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice
Time Frame
5 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Born in St.Olavs hospital, Trondheim or in Haugesund Hospital, Norway
Born with gestational age >36+6
Birth weight ≥ 2500g and <4500g
Age 1 - <15 days
Are having a blood sample performed, as newborn screening or for jaundice assessment
Exclusion criteria:
Infants needing intensive treatment. This includes:
Infants in the need for respiratory support
Infants with conditions that could compromise skin circulation, as sepsis, heart failure or other
Infants that have received phototherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siri Forsmo, md prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Haugesund Hospital
City
Haugesund
Country
Norway
Facility Name
St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
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Identification of Jaundice in Newborns Using Smartphones
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