Broad Band Emission LED Phototherapy Source Versus Narrow Band

Not Applicable

• Conditions: Neonatal Hyperbilirubinemia; Jaundice, Neonatal
• Interventions: Device: Blue-Green LED photoherapy

• Registration Number: NCT05257369
• Lead Sponsor: Erebouni Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-02
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Study First Posted: 2022-02-25
• Last Update Posted: 2022-02-25
• Primary Completion: 2022-08-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.Blue-Green LED wide band phototherapy	Blue-Green LED photoherapy	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).
2.Blue LED narrow band phototherapy	Blue-Green LED photoherapy	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).

Primary Outcome Measures

Name	Time	Method
Bilirubin level reduction	24 hours	Reduction in TSB levels after phototherapy for 24 hours

Secondary Outcome Measures

Name	Time	Method
Days of phototherapy	"Through study completion, an average of 1 month.	Duration of phototherapy

Trial Locations

Locations (1)

Erebouni Medical Centre, NICU; 🇦🇲 Yerevan, Armenia