An interventional study of Blue-Green LED photoherapy in Neonatal Hyperbilirubinemia and Jaundice, Neonatal, sponsored by Erebouni Medical Center. Status unknown at 1 site in Armenia. Open to participants aged 24 Hours to 14 Days. Per ClinicalTrials.gov, last updated 2022-02-25.
Sponsored by Erebouni Medical Center · Not applicable, Interventional, and Treatment
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.
93 studies on the registry are indexed under Hyperbilirubinemia, Neonatal; 20 are open to participants now.
This study's planned enrollment of 110 is above the median of 94 across 59 interventional studies indexed under Hyperbilirubinemia, Neonatal.
Browse Hyperbilirubinemia, Neonatal studies →Erebouni Medical Center is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
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
Bilirubin level reduction
Reduction in TSB levels after phototherapy for 24 hours
Time frame: 24 hours
Days of phototherapy
Duration of phototherapy
Time frame: "Through study completion, an average of 1 month.
Adverse outcomes
Any adverse effects or patologycal symptoms during phototherapy
Time frame: "Through study completion, an average of 1 month.
This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Erebouni Medical Center