Broad Band Emission LED Phototherapy Source Versus Narrow Band

Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice

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.

Study Overview

• Status: Recruiting
• Conditions: Neonatal Hyperbilirubinemia; Jaundice, Neonatal
• Intervention / Treatment: Device: Blue-Green LED photoherapy

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pavel Mazmanyan, Prof; Phone Number: +37491416589; Email: pavelart@gmail.com
• Study Contact Backup: Name: Gohar Margaryan, MD; Phone Number: +37496023057; Email: goharmargaryan1991@mail.ru+

Study Locations

• Armenia
  • Yerevan, Armenia
    • Recruiting
    • Erebouni Medical Centre, NICU
    • Contact: Pavel Mazmanyan, Prof; Phone Number: +37410472340; Email: pavelart@gmail.com
    • Principal Investigator: Gohar Margaryan, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1.Blue-Green LED wide band phototherapy; 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).	Device: Blue-Green LED photoherapy; 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.; Other Names: Blue LED phototherapy
Active Comparator: 2.Blue LED narrow band phototherapy; 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).	Device: Blue-Green LED photoherapy; 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.; Other Names: Blue LED phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bilirubin level reduction	Reduction in TSB levels after phototherapy for 24 hours	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of phototherapy	Duration of phototherapy	"Through study completion, an average of 1 month.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse outcomes	Any adverse effects or patologycal symptoms during phototherapy	"Through study completion, an average of 1 month.

Collaborators and Investigators

• Sponsor: Erebouni Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 25, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Phototherapy; Blue light LED; Green Light LED
• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Skin Manifestations; Jaundice; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal; Jaundice, Neonatal
• Other Study ID Numbers: 003PH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No