跳至主要内容
临床试验/NCT04719104
NCT04719104Unknown不适用

Can Transcutaneous Bilirubin (TcB) Measurements be Utilised to Assess Rebound Hyperbilirubinaemia Following Phototherapy in Neonates?

NHS Greater Glasgow and Clyde0 个研究点目标入组 200 人开始时间: 2021年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice

研究概览

简要总结

Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?

详细描述

Jaundice is common in the newborn and may result in the need for babies to be readmitted from home for phototherapy, with associated increased costs and significant family distress.

As well as prolonged hospital stay, neonates on phototherapy require multiple blood tests (SBR), generally acquired via heel prick testing. These cause the baby discomfort and samples may be insufficient or haemolyzed and require repeating. There is also a delay of one to two hours at best in results being received and actioned.

Jaundice measurements can also be obtained using non-invasive, cheap and reliable meters (TcB) that give almost immediate results. The meter takes one to two minutes to get a result and can be used at the cotside. TcB causes the baby no significant discomfort.

TcB meters are commonly used before phototherapy but are not routinely used during or after stopping phototherapy. Jaundice commonly worsens after stopping phototherapy due to release of bilirubin from tissues and so measuring a "rebound" SBR twelve hours after stopping phototherapy and before the baby can go home is routine practice.

TcB meters tend to underestimate SBR in the first eight hours after stopping phototherapy but there is some evidence that thereafter they may provide reliable results. If TcB measurements can be used as a reliable predictor for SBR twelve hours after phototherapy, this will reduce blood sampling and costs, causing less distress to the baby and their mother, with potential for earlier discharge home. The NICE guideline for neonatal jaundice suggests that new research is needed to evaluate the accuracy of different transcutaneous bilirubinometers in comparison to serum bilirubin levels in all babies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Well neonates
  • 35+0 weeks gestation or greater, over 24 hours old
  • Inpatients at Princess Royal Maternity (PRM), NHS Greater Glasgow and Clyde

排除标准

  • Unwell neonates
  • Less than 35+0 weeks' gestation
  • Less than 24 hours old
  • Mother unable or too distressed to give informed consent

结局指标

主要结局

Utility of transcutaneous bilirubinometer (TcB) in assessing rebound jaundice

时间窗: 6 months

Can the TcB be safely and effectively used to assess rebound hyperbilirubinaemia after phototherapy in babies of 35 weeks' gestation or greater?

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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