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临床试验/NCT05257369
NCT05257369Unknown不适用

Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice

Erebouni Medical Center1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
110
试验地点
1
主要终点
Bilirubin level reduction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

no masking

入排标准

年龄范围
24 Hours 至 14 Days(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Bilirubin level reduction

时间窗: 24 hours

Reduction in TSB levels after phototherapy for 24 hours

次要结局

  • Days of phototherapy("Through study completion, an average of 1 month.)

研究者

发起方
Erebouni Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pavel Mazmanyan

Prof. Pavel Mazmanyan

Erebouni Medical Center

研究点 (1)

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