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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05257369
Enrollment
110
Registered
2022-02-25
Start date
2022-01-01
Completion date
2022-12-01
Last updated
2022-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Jaundice, Neonatal, Neonatal Hyperbilirubinemia

Keywords

Phototherapy, Blue light LED, Green Light LED

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.

Interventions

DEVICEBlue-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.

Sponsors

Erebouni Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

no masking

Intervention model description

Prospective randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
24 Hours to 14 Days
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bilirubin level reduction24 hoursReduction in TSB levels after phototherapy for 24 hours

Secondary

MeasureTime frameDescription
Days of phototherapyThrough study completion, an average of 1 month.Duration of phototherapy

Other

MeasureTime frameDescription
Adverse outcomesThrough study completion, an average of 1 month.Any adverse effects or patologycal symptoms during phototherapy

Countries

Armenia

Contacts

Primary ContactPavel Mazmanyan, Prof
pavelart@gmail.com+37491416589
Backup ContactGohar Margaryan, MD
goharmargaryan1991@mail.ru++37496023057

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026