RotaNeo: Evaluation of Rotavirus Vaccine Administration in Premature Babies in the Neonatal Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of days rotavirus vaccine can be detected in stool following immunisation
研究概览
简要总结
This study will establish the duration of excretion of rotavirus vaccine in stool following vaccination of premature babies hospitalised in a neonatal unit at the time of vaccination.
详细描述
Rotavirus is the commonest cause of severe gastroenteritis in young children, and premature babies are at high risk of serious disease. The RV1 rotavirus vaccine is an altered form of the virus and is given to all children at 8 weeks and 12 weeks of age in the UK. It is given by mouth and excreted in the stool following vaccination - the vaccine virus can therefore be transmitted between people in the same way as the normal virus. Premature babies often receive their initial vaccines while they are still hospitalised in neonatal units. There are no data regarding stool excretion of the RV1 rotavirus vaccine in premature babies - there is a theoretical risk of transmission of the vaccine virus to other babies in the unit (if there was inadequate staff hand washing). Some countries have therefore advised against immunisation of babies while in the neonatal unit. In the UK, however, the vaccine is being given in neonatal units, enabling evaluation of the vaccine in hospitalised premature babies.
This is an observational study of babies admitted to the neonatal unit at the John Radcliffe Hospital, Oxford University Hospitals NHS Trust who receive their first dose of rotavirus vaccine during their hospital stay.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Weeks 至 15 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant's parent is willing and able to give informed consent for participation in the study.
- •Current inpatient in the neonatal unit and expected to remain an inpatient for at least 14 days following immunisation with rotavirus vaccine.
- •Due to receive rotavirus vaccination during their admission.
- •Born at less than 37 completed weeks gestation (i.e. up to and including 36 weeks and 6 days)
排除标准
- •Parent is listed on the study delegation log.
结局指标
主要结局
Number of days rotavirus vaccine can be detected in stool following immunisation
时间窗: 24 months
次要结局
- Measurement of serum and stool antibody to rotavirus vaccine following vaccination(24 months)
- Number of adverse events following rotavirus vaccine(12 months)
- Comparison of vaccine responses after categorisation based on GI microbiome
