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Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice

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ClinicalTrials.gov Identifier: NCT03007563
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Norwegian University of Science and Technology
University Hospital, Akershus
Information provided by (Responsible Party):
St. Olavs Hospital

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 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.


Condition or disease Intervention/treatment Phase
Jaundice, Neonatal Hyperbilirubinemia, Neonatal Device: bilirubin concentration estimation from smartphone pictures Procedure: bilirubin concentration measured in standard blood samples Device: bilirubin concentration measured by transcutaneous device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Smartphone Based Optical Diagnostic Tool for Neonatal Jaundice
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : April 1, 2019

Arm Intervention/treatment
Experimental: newborn infants checked for jaundice
an experimental way of bilirubin concentration estimation from smartphone pictures is applied and compared with two standard methods: bilirubin concentration measured in standard blood samples, and bilirubin concentration measured by transcutaneous device.
Device: bilirubin concentration estimation from smartphone pictures
pictures taken of the skin covering the breast bone

Procedure: bilirubin concentration measured in standard blood samples
Device: bilirubin concentration measured by transcutaneous device



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007563


Contacts
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Contact: Anders Aune 0047 95034601 a.aune@ntnu.no

Locations
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Norway
Akershus University Hospital Recruiting
Oslo, Norway
Contact: Britt Nakstad, MD         
Contact: Anne Lee Solevåg         
Sub-Investigator: Hanne Bui         
St Olavs Hospital Completed
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Norwegian University of Science and Technology
University Hospital, Akershus
Investigators
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Study Director: Siri Forsmo, md prof Norwegian University of Science and Technology

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Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT03007563     History of Changes
Other Study ID Numbers: 2014/619
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Diagnosis
Cell Phones
Infant, Newborn

Additional relevant MeSH terms:
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Jaundice
Jaundice, Neonatal
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs