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Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.

Primary Purpose

Neonatal Jaundice

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Phototherapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neonatal Jaundice

Eligibility Criteria

25 Hours - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Indication for phototherapy with single light
  • Gestational age > 33 weeks
  • Birth weight > 1800 grams
  • Should be treatable in a cradle

Exclusion Criteria:

  • Haemolytic disease
  • Indication for double/triple phototherapy or exchange transfusion

Sites / Locations

  • Neonatal department, Aalborg University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phototherapy 478 nm

Phototherapy 459 nm

Arm Description

The jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.

The jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.

Outcomes

Primary Outcome Measures

Decrease of total serum bilirubin

Secondary Outcome Measures

Full Information

First Posted
June 9, 2017
Last Updated
June 19, 2017
Sponsor
University of Aarhus
Collaborators
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03183986
Brief Title
Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
Official Title
Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Anticipated)
Study Completion Date
July 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.
Detailed Description
This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age > 33 weeks and birth weight > 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes. Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Infants are randomised to phototherapy with blue LED's with wavelength of 478 or 459 nm. The decrease of TSB between the groups is compared.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phototherapy 478 nm
Arm Type
Active Comparator
Arm Description
The jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.
Arm Title
Phototherapy 459 nm
Arm Type
Active Comparator
Arm Description
The jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.
Intervention Type
Device
Intervention Name(s)
Phototherapy
Intervention Description
Phototherapy for 24 hours.
Primary Outcome Measure Information:
Title
Decrease of total serum bilirubin
Time Frame
24 hours of phototherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Hours
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Indication for phototherapy with single light Gestational age > 33 weeks Birth weight > 1800 grams Should be treatable in a cradle Exclusion Criteria: Haemolytic disease Indication for double/triple phototherapy or exchange transfusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pernille K Vandborg, MD, PhD
Phone
+ 45 26131711
Email
pervan@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Mette R Donneborg, MD
Phone
+ 45 22406344
Email
mld@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Donneborg, MD
Organizational Affiliation
Aalborg University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatal department, Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mette Donneborg, MD
Phone
+45 22406344
Email
mld@rn.dk
First Name & Middle Initial & Last Name & Degree
Finn Ebbesen, Professor, MD
Phone
+ 45 97663330
Email
fe@rn.dk
First Name & Middle Initial & Last Name & Degree
Mette Donneborg, MD
First Name & Middle Initial & Last Name & Degree
Pernille Vandborg, MD, PhD
First Name & Middle Initial & Last Name & Degree
Finn Ebbesen, DmSci

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27235206
Citation
Lamola AA. A Pharmacologic View of Phototherapy. Clin Perinatol. 2016 Jun;43(2):259-76. doi: 10.1016/j.clp.2016.01.004. Epub 2016 Feb 15.
Results Reference
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Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.

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