Comparison of the Efficacy of Phototherapy With Wavelength 478 vs. 459 nm for Treatment of Neonatal Jaundice Using Blue LED's.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Decrease of total serum bilirubin
研究概览
简要总结
Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing total serum bilirubin. The aim of this study is therefore to compare the efficiency of phototherapy with light emitting diodes (LED's) of 478 vs. 459 nm., respectively.
详细描述
This is a prospective randomised study of the efficacy of phototherapy. Inclusion criteria are gestational age > 33 weeks and birth weight > 1800 grams, uncomplicated neonatal jaundice. The infants should be treated with phototherapy in a cradle for 24 hours, which is routine standard of care. Exclusion criteria is haemolytic disease. Total serum bilirubin (TSB) is measured before and after 24 hours of phototherapy. The infants are enrolled and randomised consecutively by the neonatologist using sealed and opaque envelopes.
Power calculation based on expected difference in decrease of TSB of 6% between the two groups and a significance level of 0.05, showed that 48 infants should be enrolled in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for phototherapy with single light
- •Gestational age > 33 weeks
- •Birth weight > 1800 grams
- •Should be treatable in a cradle
排除标准
- •Haemolytic disease
- •Indication for double/triple phototherapy or exchange transfusion
研究组 & 干预措施
Phototherapy 478 nm
The jaundiced neonates receives phototherapy with blue light from above at wavelength 478 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.
干预措施: Phototherapy (Device)
Phototherapy 459 nm
The jaundiced neonates receives phototherapy with blue light from above at wavelength 459 nm. They are treated for 24 hours, which is standard treatment for neonatal jaundice.
干预措施: Phototherapy (Device)
结局指标
主要结局
Decrease of total serum bilirubin
时间窗: 24 hours of phototherapy
次要结局
未报告次要终点
研究者
Pernille Kure Vandborg
Principal investigator, MD, PhD.
University of Aarhus