Identification of Jaundice in Newborns Using Smartphones

NCT04182555 | Completed

• 1 other identifier: 2018/1608
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal

Keywords

Diagnosis; Cell Phones; Infant, Newborn; Skin Pigmentation

Outcome Measures

Primary Outcomes (1)

• Smartphone application sensitivity

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

  5 minutes

Secondary Outcomes (4)

• Repeatability

  5 min

• Correlation between bilirubin estimates by smartphone pictures and by total serum bilirubin

  5 minutes

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

  5 minutes

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

  5 min

Study Arms (1)

Newborns in St.Olavs Hospital and Haugesund Hospital

EXPERIMENTAL

All newborns will be examined through 4 different methods of determining jaundice.

Device: Bilirubin estimates from Smartphone Application; Diagnostic Test: Bilirubin concentration measured in standard blood samples; Device: Bilirubin estimates from standard transcutaneous device; Other: Visual assessment of jaundice

Interventions

Bilirubin estimates from Smartphone Application DEVICE

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

Newborns in St.Olavs Hospital and Haugesund Hospital

Bilirubin concentration measured in standard blood samples DIAGNOSTIC_TEST

Bilirubin measured in total serum bilirubin.

Newborns in St.Olavs Hospital and Haugesund Hospital

Bilirubin estimates from standard transcutaneous device DEVICE

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

Newborns in St.Olavs Hospital and Haugesund Hospital

Visual assessment of jaundice OTHER

Degree of jaundice will be assessed by Kramer scale

Newborns in St.Olavs Hospital and Haugesund Hospital

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator
• Helse Fonna: collaborator

Study Sites (2)

Haugesund Hospital

Haugesund, Norway

Location

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Disease; Pigmentation Disorders

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Siri Forsmo, md prof

  Norwegian University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 200 newborns with varying degree of jaundice will be recruited.

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 2, 2019
• Study Start: August 3, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: September 26, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)