Broad Band Emission LED Phototherapy Source Versus Narrow Band

Erebouni Medical Center

Status: Unknown

Conditions: Neonatal Hyperbilirubinemia; Jaundice, Neonatal

Treatments: Device: Blue-Green LED photoherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05257369

003PH

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 24 hours to 14 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

1.Blue-Green LED wide band phototherapy

Experimental group

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).

Treatment:

Device: Blue-Green LED photoherapy

2.Blue LED narrow band phototherapy

Active Comparator group

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).

Treatment:

Device: Blue-Green LED photoherapy