Baby-CINO: CaffeINe Treatment Optimisation in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Brain activity
研究概览
简要总结
This study investigates how brain activity and breathing changes in premature babies when their dose of caffeine treatment is changed or stopped. The study will assess premature babies receiving caffeine treatment as part of their clinical care. Brain activity will be recorded just before caffeine dose is changed and again two days afterwards. Breathing and other 'vital signs' (breathing rate, heart rate, oxygen saturation) will be recorded from the baby's monitor between the recordings of brain activity and for up to two weeks afterwards.
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
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born to a mother aged 16 or over
- •Admitted to the Newborn Care Unit, John Radcliffe Hospital
- •Born prematurely (before 37 weeks' gestation)
- •Parent given informed written consent
- •Receiving caffeine citrate
排除标准
- •Known chromosomal abnormality or life-threatening congenital abnormality
- •Severe hypoxic insult at birth
- •Intraventricular haemorrhage grade III or IV or other severe neurological pathology
研究组 & 干预措施
Preterm infant
Preterm infants receiving caffeine (prescribed clinically) will be studied
干预措施: Caffeine (Drug)
结局指标
主要结局
Brain activity
时间窗: From baseline to two days later
Change in EEG activity between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
Respiration
时间窗: From baseline to two days later
Change in respiratory dynamics between baseline (time at which caffeine dose is changed/treatment ends) and approximately 2 days later
次要结局
- Heart rate(From baseline to two days later)
- Oxygen saturation(From baseline to two days later)