Home Phototherapy for Term Newborns With Icterus, a Clinical Randomized Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 5
- 主要终点
- Change in parent-child bonding
研究概览
简要总结
The study is designed as a randomised controlled multicenter study.The primary aim is to investigate if home phototherapy improves parent-child bonding compared to if treatment is performed at the hospital. The investigators will also istudy how home phototherapy is perceived by the parents, impact on breastfeeding and parents stress levels, if the method can be implemented etc.
Patients are included at 5 hospitals in Sweden. The plan is to include 250 term newborns with neonatal icterus at a level that needs phototherapy treatment.
详细描述
Background: Almost half of all newborns develops jaundice, due to elevated levels of bilirubin. If levels are high phototherapy is needed to reduce the levels of bilirubin. Presently most children with neonatal jaundice in Sweden receives phototherapy admitted to hospital. There is fiberoptic equipment available that can be used at home to treat the newborns.
Aim: Primary aim is to investigate if parent-child bonding is improved with home phototherapy compared to phototherapy performed at the hospital.
Method:The study is designed as a randomised controlled multicenter study. Eligible parents and newborns are randomised to either treatment at home or at the hospital. Demographic data about the newborn such as for example apgar score, gender, time of birth etc are registered. At time of discharge parents answers questionnaires such as for example the Postpartum Bonding Questionnaire (PBQ), the Edinburgh Postnatal Depression Scale (EDPS), the Swedish Parenthood Stress Questionnaire etc. Parents experiences from home phototherapy will also be investigated through semistructured interviews.
Parents will asked to answer questionnaires at the time of discharge as well as at 4-months after discharge.
Analysis of data will be performed by using conventional parametric and non-parametric statistical methods.
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
- Single (Investigator)
盲法说明
Group allocation blinded to the investigator.
入排标准
- 年龄范围
- 48 Hours 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age w36-
- •Age of newborn 48 hours or more.
- •Level of bilirubin 300-400 µmol/l
排除标准
- •Immunisation. Bilirubin >400 µmol/l. Asphyxia. Ongoing infection, weightloss > 10%, other severe disease, parents who don´t speak Swedish, parents that are not expected to be able to handle the home phototherapy equipment
研究组 & 干预措施
Phototherapy at hospital
Newborns with icterus that receive treatment while being admitted to hospital.
Home phototherapy
Newborns with icterus receiving phototherapy at home.
干预措施: home phototherapy (Other)
结局指标
主要结局
Change in parent-child bonding
时间窗: Change from discharge to 4-months after discharge
Measured by parents answering the Postpartum Bonding questionnaire. Score range 0-125, higher is worse.
次要结局
- Change in mothers experience of breastfeeding(Change from discharge to 4 months after discharge)
- Transcutaneous bilirubin measurement, and how it is affected by phototherapy(measurements are performed from date of randomization until discharge, assessed up to 4 weeks of age.)
- Parental stress(at 4 months after discharge)
- Change in parents emotional status(Change from discharge to 4 months after discharge)
- Change in health-related Life quality(Change from discharge to 4 months after discharge)