Efficacy of Reverse Phototherapy With Super Light-emitting Diode(Super-led) in Term and Late Preterm Infants:Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Bilirubinemia
研究概览
简要总结
The aim of this study is to compare the efficacy of super-LED reverse phototherapy with the fluorescent reverse phototherapy in term and late preterm newborns.
详细描述
This is a randomized controlled clinical trial with hospitalized infants in the Professor Fernando Figueira Medicine Institute(IMIP), who require phototherapy as an indication of the medical team. Following the sample calculation, 144 patients will be randomized according to gestational age (350/7-376/7 or 380/7-416/7 weeks) to receive super-LED reverse phototherapy or fluorescent reverse phototherapy with spectral irradiance of 8-12 microwatts/cm2/nm.The bilirubin will be determined by micromethod with bilirubinometer, after blood collection in heparinized capillary until bilirubin reaches level that indicates suspension of therapy.
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
- None
入排标准
- 年龄范围
- 35 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns in the maternity Professor Fernando Figueira Medicine Institute(IMIP)
- •Gestational age between 350/7 and 416/7 weeks
- •Birth weight greater than 2200g
- •Absence of congenital malformations
- •indication of phototherapy after 48 hours of life
- •Terms of consent signed by parent or guardian
排除标准
- •Total Bilirubin level indicative of phototherapy intensive or exchange transfusion
- •RH incompatibility hemolytic disease
- •Mother's refusal to continue to participate in the study
- •Unavailability of the two types of phototherapy equipment for randomization
- •Mother or newborn who received phenobarbital
结局指标
主要结局
Bilirubinemia
时间窗: 24 hours
Bilirubin seric level decrease after 24 hours of phototherapy
次要结局
- Phototherapy Time(24 to 48 hours)
- Adverse Effects(24 to 48 hours)
- Treatment Cost(24 to 48 hours)
- Treatment Failure(24 to 48 hours)
- Rebound Hyperbilirubinemia(24 hours)