Clinical trial NCT04182555: Identification of Jaundice in Newborns Using Smartphones
Official title: Identification of Jaundice in Newborns Using Smartphones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaundice, Neonatal
Hyperbilirubinemia, Neonatal
Keywords: Diagnosis
Cell Phones
Infant, Newborn
Skin Pigmentation
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: Helse Fonna
First posted: 2019-12-02
Enrollment: 220
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 200 newborns with varying degree of jaundice will be recruited.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Smartphone application sensitivity
timeFrame: 5 minutes
Secondary outcomes:
measure: Repeatability
timeFrame: 5 min
measure: Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin
timeFrame: 5 minutes
measure: Correlation between bilirubin estimates by smartphone pictures and by standard transcutaneous readings.
timeFrame: 5 minutes
measure: Correlation between bilirubin estimates by smartphone pictures and visual assessment of jaundice
timeFrame: 5 min
Other outcomes:
Locations:
city: Haugesund
country: Norway
facility: Haugesund Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Siri Forsmo, md prof
role: STUDY_DIRECTOR
References: