Broad Band Emission LED Phototherapy Source Versus Narrow Band

NCT ID: NCT05257369

Last Updated: 2022-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Neonatal Hyperbilirubinemia Jaundice, Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
no masking

Study Groups

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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).

Group Type EXPERIMENTAL

Blue-Green LED photoherapy

Intervention Type DEVICE

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.

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).

Group Type ACTIVE_COMPARATOR

Blue-Green LED photoherapy

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Blue LED phototherapy

Eligibility Criteria

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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.
Minimum Eligible Age

24 Hours

Maximum Eligible Age

14 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erebouni Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pavel Mazmanyan

Prof. Pavel Mazmanyan

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erebouni Medical Centre, NICU

Yerevan, , Armenia

Site Status RECRUITING

Countries

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Armenia

Central Contacts

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Pavel Mazmanyan, Prof

Role: CONTACT

+37491416589

Gohar Margaryan, MD

Role: CONTACT

+37496023057

Facility Contacts

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Pavel Mazmanyan, Prof

Role: primary

+37410472340

Other Identifiers

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003PH

Identifier Type: -

Identifier Source: org_study_id

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