Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,858
- 试验地点
- 2
- 主要终点
- Readmission for hyperbilirubinemia
研究概览
简要总结
In South Africa, healthy term newborns are usually discharged early (<72 hours after delivery). Many studies have shown that hospital readmission rates have increased with this practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have already been discharged putting the infant at increased risk of severe hyperbilirubinemia. Severe neonatal jaundice still constitutes an important cause of neonatal mortality and morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before hospital could help in early identification of hyperbilirubinemia and early intervention and potentially prevent unwanted consequences like bilirubin induced neurological dysfunction. However, there are conflicting recommendations on the use of universal transcutaneous bilirubin screening for jaundice in all newborns before hospital discharge.
详细描述
Like in many other countries in Africa and the rest of the world, objective screening for risk of severe hyperbilirubinemia using serum bilirubin (TsB) or transcutaneous bilirubin (TcB) measurement is currently not standard of care in South Africa. The investigators therefore propose to test the use of a non-invasive TcB device to detect and predict the risk of severe jaundice before discharge of babies from the new-born nursery in a South African population of newborns.
OBJECTIVE To evaluate the effects of transcutaneous bilirubin screening in newborns before hospital discharge.
METHODS In this randomised controlled trial (RCT) the investigators will compare the traditional visual assessment and TcB measurement before hospital discharge. About 1858 newborns ≥35 weeks gestational age and/or ≥1800 g, who are <72 hrs of life will be randomly allocated into two groups: a) TcB screening, or b) visual assessment (standard care)
Subjects:
Babies ≥ 35 wks gestational age and/or ≥ 1800g, who are <72 hrs of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Hours 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All newborns ≥ 35 wks gestational age and ≥ 1800g
- •Babies who who are < 72 hours of life
排除标准
- •Prior use of phototherapy
- •Major congenital anomaly
- •Babies born < 35 wks gestational age or < 1800g
结局指标
主要结局
Readmission for hyperbilirubinemia
时间窗: Up to two weeks
The primary outcome is readmission for hyperbilirubinemia requiring phototherapy or exchange transfusion
次要结局
- TsB > 427 umol/l or TsB > threshold for exchange transfusion(Up to two weeks)
- Length of hospital stay (days)(Up to two weeks)
- Blood draw for total serum bilirubin(Up to two week)
- Phototherapy before discharge(Up to two weeks)
研究者
Charles Okwundu
Researcher
University of Stellenbosch