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Completed

NCT Number: NCT03007563

Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

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 has been developed. This prototype will be evaluated in a clinical trial in two hospitals in Norway. A smartphone will be used to take picture of the skin of the newborn, and by using an algorithm an estimate of the bilirubin concentration is made. The results from 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

Age range

1 day–14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital, Oslo, Norway

Loading trial locations.

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 Akershus hospital, Oslo, Norway
  • born at term
  • normal birth weight

Exclusion criteria

  • in need of advanced medical treatment

Treatment and study plan

bilirubin concentration estimation from smartphone pictures

Device

pictures taken of the skin covering the breast bone

bilirubin concentration measured in standard blood samples

Procedure

bilirubin concentration measured by transcutaneous device

Device

Primary outcomes

  1. Correlation between bilirubin estimates by smartphone pictures and by blood samples

    Time frame: 5 minutes

    Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurement in blood samples in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.

  2. Correlation between bilirubin estimates by smartphone pictures and by transcutaneous measurements

    Time frame: 5 minutes

    Estimate of bilirubin levels from smartphone pictures, compared with bilirubin measurements from transcutaneous devices in a correlation study. Correlation will be expressed by Pearson correlation coefficient, r.

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian University of Science and Technology
  • University Hospital, Akershus

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2017
Registry last updated
Apr 13, 2020

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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