Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy for Treatment of Neonatal Hyperbilirubinemia
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Questionnaire on the parents experience with the phototherapy treatment
研究概览
简要总结
A randomized study of phototherapy for neonatal hyperbilirubinemia. The intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. Both treatments are well known and used. The primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.
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
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonatal icterus and total serum bilirubin above threshold for phototherapy.
- •Gestational age ≥ 33 weeks
- •Birth weight ≥ 1800 gr
- •Postnatal age > 24 hours and < 2 weeks
排除标准
- •Hemolysis due to isoimmunization
- •Very high or rapidly rising total serum bilirubin
研究组 & 干预措施
Bili Cocoon
The infants will be treated with phototherapy using a double sided fiber optic pad called Bili Cocoon with an irradiance of 30 uW/cm2/nm from both sides.
干预措施: Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon (Device)
Conventional blue light
The infants will be treated with blue light from above at 30 Uw/cm2/nm which is the standard treatment.
干预措施: Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm (Device)
结局指标
主要结局
Questionnaire on the parents experience with the phototherapy treatment
时间窗: Day 1 of phototherapy
Parents experience of phototherapy. Questions at time of beginning phototherapy (1): "What did you feel at the time your baby started treatment with phototherapy?" Questions after phototherapy (2): "What did you experience with your baby during the time of phototherapy?" The parents answer on a scale from "I agree, I partly agree, N/A, I partly disagreee, I disagree" Examples of questions: "I felt well informed about the indication and use of phototherapy" (Answer: I agree, partly agree, disagreee etc,) "I was difficult to breastfeed while my baby was on phototherapy" (Answer as above described)
次要结局
- Effect of phototherapy(Measurement of bilirubin before phototherapy and after 24 hours)