Close Range Immersive Phototherapy Vs Standard Phototherapy in babies with hyperbilirubinemia (CRimP) – A randomized control trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in bilirubin levels by 5%
研究概览
简要总结
Jaundice occurs in more than 85% of new-borns during the first days of life. Significant increase in free bilirubin levels are usually toxic and cause damage to the development of the central nervous system. Phototherapy, exchange transfusion and pharmacological agents are the different mode of treatment for hyperbilirubinemia.
Phototherapy is one of the commonly used non-invasive mode of treatment. The most effective light source to degrade bilirubin is at a wavelength between 420 and 460 nanometers. The blue – green spectrum emitting light at required wavelength and irradiance are considered to be more effective to be used in phototherapy.
Though Blue light phototherapy has been used frequently for management of hyperbilirubinemia, studies have shown many side effects of blue light. Continuous exposure to blue light was noticed to have various side effects like dry eyes, blurring, headache altered circadian rhythm causing disruption in sleep cycle and performance.
With blue light causing these side effects, with the intention of preventing unnecessary exposure of health care personnel to blue light used during neonatal phototherapy, a close-range immersive phototherapy (CRimP) unit was devised to contain the spread of blue light. This study aims to compare the efficacy of CRimP against the standard phototherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 30.00 Day(s)(—)
- 性别
- All
入选标准
- •All stable neonates with hyperbilirubinemia requiring phototherapy.
排除标准
- •Babies who are sick on mechanical ventilation, requiring inotropes and babies requiring exchange transfusion.
结局指标
主要结局
Reduction in bilirubin levels by 5%
时间窗: 6 hrs
次要结局
未报告次要终点
