Comparison of two irradiance levels for efficacy of phototherapy in LED phototherapy device: A randomized controlled trial in infants at or above 35 weeks GA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- To compare the total duration of phototherapy (O ) in healthy late preterm and term neonates with hyperbilirubinemia during first week of life (P) treated with LED Phototherapy device , high level of irradiance (45±5µW/cm2/nm) (I) compared to low level of irradiance (22.5±5 µW/cm2/nm)
研究概览
简要总结
)Jaundice is a very common problem in neonates and phototherapy is a safe, effective and first line of management .There are very less studies working with higher level of irradiance(doses of light intensity) for effectiveness of phototherapy. our study hypothesis is that increasing the irradiance of phototherapy will increase the efficacy of phototherapy in terms of total duration of phototherapy and rate of fall of bilirubin, at the same time looking out any adverse effect of higher irradiance .
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •â€¢Late Preterm & Term (≥34 weeks and <42 wk) •Development of jaundice in 1st week with TSB levels requiring phototherapy as per AAP criteria.
排除标准
- •â€¢Rh haemolytic disease •Major Congenital Anomalies •No availability of a working phototherapy unit •Refusal to consent.
结局指标
主要结局
To compare the total duration of phototherapy (O ) in healthy late preterm and term neonates with hyperbilirubinemia during first week of life (P) treated with LED Phototherapy device , high level of irradiance (45±5µW/cm2/nm) (I) compared to low level of irradiance (22.5±5 µW/cm2/nm)
时间窗: the total duration of phototherapy till 2 serum bilirubin values are below cutoff values .
次要结局
- To compare the effect of increasing irradiance on:(1.The rate of fall of bilirubin in first 24 hours of initiating phototherapy)