- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154165
Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Aalborg, Denmark, 9000
- Neonatal department, Aalborg University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Blue light wavelenght 460 nm
|
The infants were randomized to phototherapy with either blue og turquoise light
|
Active Comparator: Turquoise light wavelength 499 nm
|
The infants were randomized to phototherapy with either blue og turquoise light
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in total serum bilirubin
Time Frame: 24 hours
|
The infants were treated with phototherapy for 24 hours, which is the standard treatment.
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PKV 2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uncomplicated Neonatal Hyperbilirubinemia
-
Guangzhou Women and Children's Medical CenterRecruitingNeonatal Hyperbilirubinemia | Neonatal Jaundice | Hemolysis NeonatalChina
-
HonorHealth Research InstituteNeolightCompletedNeonatal Hyperbilirubinemia | Jaundice, Neonatal | Neonatal DisorderUnited States
-
National Liver Institute, EgyptCompleted
-
Erebouni Medical CenterRecruitingNeonatal Hyperbilirubinemia | Jaundice, NeonatalArmenia
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruitingNeonatal HyperbilirubinemiaChina
-
Region Örebro CountyCompleted
-
University of PatrasCompleted
-
Hacettepe UniversityCompletedHyperbilirubinemia, Neonatal IndirectTurkey
-
Princess Amalia Children's ClinicNot yet recruiting
-
University of OxfordKinshasa School of Public HealthCompletedNeonatal HyperbilirubinemiaCongo, The Democratic Republic of the
Clinical Trials on Phototherapy
-
University of Nove de JulhoCompletedPhotobiomodulation In the Masseter and Temporal In Patients With Temporomandibular Joint DysfunctionTemporomandibular Disorder
-
University of ZurichCompletedPsoriasis | EczemaSwitzerland
-
Nathalie CharpakHospital Universitario San Ignacio; Pontificia Universidad JaverianaCompletedPhototherapy | Jaundice, NeonatalColombia
-
University of Nove de JulhoUnknownTemporomandibular Disorder.Brazil
-
Shin Kong Wu Ho-Su Memorial HospitalCompletedBrief Description of Focus of Study InsteadTaiwan
-
Istituti Fisioterapici OspitalieriUnknown
-
University of Nove de JulhoFundação de Amparo à Pesquisa do Estado de São PauloCompletedExcessive Physical Exercise, UnspecifiedBrazil
-
University of MinnesotaThrasher Research FundCompletedFiltered Sunlight Phototherapy to Treat Significant Jaundice: Safety and Efficacy in Neonates (FSPT)Jaundice, NeonatalNigeria
-
University of MinnesotaThrasher Research FundCompletedJaundice, NeonatalNigeria
-
Henry Ford Health SystemWithdrawn