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Completed

NCT Number: NCT04182555

Identification of Jaundice in Newborns Using Smartphones

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.

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Key information

Conditions

Jaundice, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Hyperbilirubinemia Hyperbilirubinemia, Neonatal Infant, Newborn, Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haugesund Hospital, Haugesund, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilirubin estimates from Smartphone Application

Device

Bilirubin estimates through color analysis of digital images obtained through smartphone application.

Bilirubin concentration measured in standard blood samples

Diagnostic Test

Bilirubin measured in total serum bilirubin.

Bilirubin estimates from standard transcutaneous device

Device

Bilirubin estimates performed by transcutaneous device ( Dräger JM-105)

Visual assessment of jaundice

Other

Degree of jaundice will be assessed by Kramer scale

Primary outcomes

  1. Smartphone application sensitivity

    Time frame: 5 minutes

    Sensitivity of the smartphone application to detect severe jaundice, defined as total serum bilirubin value > 250 umol/l.

Secondary outcomes

  1. Repeatability

    Time frame: 5 min

    To evaluate the repeatability of multiple measurements with the new smartphone tool

  2. Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin

    Time frame: 5 minutes

    Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements in total serum. Correlation will be expressed by Pearson correlation coefficient, r.

  3. Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.

    Time frame: 5 minutes

    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.

  4. Correlation between bilirubin estimates by smartphone pictures and visual assessment of jaundice

    Time frame: 5 min

    • To evaluate the correlation between bilirubin estimates from a smartphone application and bilirubin estimates from visual inspection in newborns with varying degree of jaundice

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Helse Fonna
  • Norwegian University of Science and Technology

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 2, 2019
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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