Broad Band Emission LED Phototherapy Source Versus Narrow Band

NCT05257369 | Unknown

• 1 other identifier: 003PH
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Hyperbilirubinemia; Jaundice, Neonatal

Keywords

Phototherapy; Blue light LED; Green Light LED

Outcome Measures

Primary Outcomes (1)

• Bilirubin level reduction

  Reduction in TSB levels after phototherapy for 24 hours

  24 hours

Secondary Outcomes (1)

• Days of phototherapy

  "Through study completion, an average of 1 month.

Other Outcomes (1)

• Adverse outcomes

  "Through study completion, an average of 1 month.

Study Arms (2)

1.Blue-Green LED wide band phototherapy

EXPERIMENTAL

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

2.Blue LED narrow band phototherapy

ACTIVE COMPARATOR

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

Interventions

Blue-Green LED photoherapy 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.

Also known as: Blue LED phototherapy

1.Blue-Green LED wide band phototherapy; 2.Blue LED narrow band phototherapy

Eligibility Criteria

• Age: 24 Hours - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• hemolytic jaundice, major congenital animalities and history of phototherapy. Infants with indication of intensive treatment double phototherapy were not included.

Sponsors & Collaborators

• Erebouni Medical Center: lead

Study Sites (1)

Erebouni Medical Centre, NICU

Yerevan, Armenia

RECRUITING

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal; Jaundice, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pavel Mazmanyan, Prof

CONTACT

+37491416589; pavelart@gmail.com

Gohar Margaryan, MD

CONTACT

+37496023057; goharmargaryan1991@mail.ru+

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: no masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Pavel Mazmanyan

Model Details: Prospective randomized controlled trial

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 25, 2022
• Study Start: January 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

AR (1)