Back to resultsComparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
Primary Purpose
Uncomplicated Neonatal Hyperbilirubinemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Phototherapy
Sponsored by
About this trial
This is an interventional treatment trial for Uncomplicated Neonatal Hyperbilirubinemia focused on measuring Neonatal hyperbilirubinemia, Phototherapy, Light emitting diodes, Blue light, Turquoise light
Eligibility 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
Sites / Locations
- Neonatal department, Aalborg University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Blue light wavelenght 460 nm
Turquoise light wavelength 499 nm
Arm Description
Outcomes
Primary Outcome Measures
Decrease in total serum bilirubin
The infants were treated with phototherapy for 24 hours, which is the standard treatment.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02154165
Brief Title
Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
Official Title
Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncomplicated Neonatal Hyperbilirubinemia
Keywords
Neonatal hyperbilirubinemia, Phototherapy, Light emitting diodes, Blue light, Turquoise light
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blue light wavelenght 460 nm
Arm Type
Active Comparator
Arm Title
Turquoise light wavelength 499 nm
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Phototherapy
Intervention Description
The infants were randomized to phototherapy with either blue og turquoise light
Primary Outcome Measure Information:
Title
Decrease in total serum bilirubin
Description
The infants were treated with phototherapy for 24 hours, which is the standard treatment.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Neonatal department, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
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