Broad Band Emission LED Phototherapy Source Versus Narrow Band
Primary Purpose
Neonatal Hyperbilirubinemia, Jaundice, Neonatal
Status
Recruiting
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
Blue-Green LED photoherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hyperbilirubinemia focused on measuring Phototherapy, Blue light LED, Green Light LED
Eligibility Criteria
Inclusion Criteria:
- non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on NICE criteria, gestational age ≥33 weeks, birth weight ≥1800 g, postnatal age >24 hrs and ≤14 days
Exclusion Criteria:
- hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included.
Sites / Locations
- Erebouni Medical Centre, NICURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1.Blue-Green LED wide band phototherapy
2.Blue LED narrow band phototherapy
Arm Description
For experimental group was used "Malysh" phototherapeutic device (Luzar ltd, Belarus); it includes of eighteen blue- green super bright LEDs (12 blue (λmax 476 ) and 6 green (505 nm).
For control group was used blue LED BILI-THERAPY (Atom Medical Inc., Tokyo, Japan) in high-mode which have a 20 μW/cm2 with peak wavelength between (λmax 480 nm).
Outcomes
Primary Outcome Measures
Bilirubin level reduction
Reduction in TSB levels after phototherapy for 24 hours
Secondary Outcome Measures
Days of phototherapy
Duration of phototherapy
Full Information
NCT ID
NCT05257369
First Posted
February 8, 2022
Last Updated
February 16, 2022
Sponsor
Erebouni Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05257369
Brief Title
Broad Band Emission LED Phototherapy Source Versus Narrow Band
Official Title
Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erebouni Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hyperbilirubinemia, Jaundice, Neonatal
Keywords
Phototherapy, Blue light LED, Green Light LED
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized controlled trial
Masking
Outcomes Assessor
Masking Description
no masking
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1.Blue-Green LED wide band phototherapy
Arm Type
Experimental
Arm Description
For experimental group was used "Malysh" phototherapeutic device (Luzar ltd, Belarus); it includes of eighteen blue- green super bright LEDs (12 blue (λmax 476 ) and 6 green (505 nm).
Arm Title
2.Blue LED narrow band phototherapy
Arm Type
Active Comparator
Arm Description
For control group was used blue LED BILI-THERAPY (Atom Medical Inc., Tokyo, Japan) in high-mode which have a 20 μW/cm2 with peak wavelength between (λmax 480 nm).
Intervention Type
Device
Intervention Name(s)
Blue-Green LED photoherapy
Other Intervention Name(s)
Blue LED phototherapy
Intervention Description
Continuous phototherapy for 24 h, for newborns placed incubators or radiant warmers will interrupted only for feeding and nursing for 20 - 30 min every three hours.
Primary Outcome Measure Information:
Title
Bilirubin level reduction
Description
Reduction in TSB levels after phototherapy for 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Days of phototherapy
Description
Duration of phototherapy
Time Frame
"Through study completion, an average of 1 month.
Other Pre-specified Outcome Measures:
Title
Adverse outcomes
Description
Any adverse effects or patologycal symptoms during phototherapy
Time Frame
"Through study completion, an average of 1 month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-haemolytic hyperbilirubinaemia, but otherwise healthy, indications for phototherapy based on NICE criteria, gestational age ≥33 weeks, birth weight ≥1800 g, postnatal age >24 hrs and ≤14 days
Exclusion Criteria:
hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pavel Mazmanyan, Prof
Phone
+37491416589
Email
pavelart@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gohar Margaryan, MD
Phone
+37496023057
Email
goharmargaryan1991@mail.ru+
Facility Information:
Facility Name
Erebouni Medical Centre, NICU
City
Yerevan
Country
Armenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pavel Mazmanyan, Prof
Phone
+37410472340
Email
pavelart@gmail.com
First Name & Middle Initial & Last Name & Degree
Gohar Margaryan, Dr
12. IPD Sharing Statement
Learn more about this trial
Broad Band Emission LED Phototherapy Source Versus Narrow Band
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