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Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes

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ClinicalTrials.gov Identifier: NCT02154165
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Helene Nørrelund, University of Aarhus

Brief Summary:

The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S).

The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks and uncomplicated hyperbilirubinemia.


Condition or disease Intervention/treatment Phase
Uncomplicated Neonatal Hyperbilirubinemia Other: Phototherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
Active Comparator: Blue light wavelenght 460 nm Other: Phototherapy
The infants were randomized to phototherapy with either blue og turquoise light

Active Comparator: Turquoise light wavelength 499 nm Other: Phototherapy
The infants were randomized to phototherapy with either blue og turquoise light




Primary Outcome Measures :
  1. Decrease in total serum bilirubin [ Time Frame: 24 hours ]
    The infants were treated with phototherapy for 24 hours, which is the standard treatment.



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Ages Eligible for Study:   33 Weeks and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newborns with gestational age >33 weeks and neonatal hyperbilirubinemia requiring treatment with phototherapy according to the national guidelines

Exclusion Criteria:

  • Haemolytic disease (Rhesus and Kell blood type isoimmunization, spherocytosis)
  • Liver disease

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): NCT02154165


Locations
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Denmark
Neonatal department, Aalborg University Hospital
Aalborg, Denmark, 9000
Sponsors and Collaborators
University of Aarhus

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Responsible Party: Helene Nørrelund, MD, University of Aarhus
ClinicalTrials.gov Identifier: NCT02154165     History of Changes
Other Study ID Numbers: PKV 2013
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014

Keywords provided by Helene Nørrelund, University of Aarhus:
Neonatal hyperbilirubinemia
Phototherapy
Light emitting diodes
Blue light
Turquoise light

Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Infant, Newborn, Diseases