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

Uncomplicated Neonatal Hyperbilirubinemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02154165
• Other study ID #: PKV 2013
• Status: Completed
• Phase: N/A
• First received: May 30, 2014
• Last updated: June 2, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 33 Weeks and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice, Neonatal
• Uncomplicated Neonatal Hyperbilirubinemia

Intervention

Other:
• Phototherapy
The infants were randomized to phototherapy with either blue og turquoise light

Locations

Country	Name	City	State
Denmark	Neonatal department, Aalborg University Hospital	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in total serum bilirubin	The infants were treated with phototherapy for 24 hours, which is the standard treatment.	24 hours	No