Clinical Efficacy of LED Phototherapy Devices With Blue - Green Versus Blue Light of Equal Irradiance in Neonates With Non Hemolytic Jaundice
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
- 否
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
Pavel Mazmanyan
Prof. Pavel Mazmanyan
Erebouni Medical Center
