Sonographic Quantification of Venous Circulation in the Preterm Brain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Normative values of internal cerebral vein velocity
研究概览
简要总结
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury.
In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations.
In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
详细描述
The aim of the study is to develop an accessible, reproducible ultrasound tool for objective clinical measurement of brain circulation in preterm infants in order to identify infants being at risk for preterm brain injury at an early stage. In the future, the results of this study might be useful to select those infants for early interventions aimed at preventing brain injury.
In this study we will identify the normative values of the internal cerebral vein velocity in a reference cohort of stable preterm infants. This stable group of preterm infants is defined as all preterm infants with a birth weight appropriate for gestational age, and without major complications (such as a severe intracranial hemorrhage, severe hemodynamical instability, birth asphyxia) or major congenital malformations.
In this group we will identify subgroups based on moments of clinical instability (sepsis, temporary hypotension, NEC, need for invasive respiratory support) or based on outcome parameters (IVH, PVL, developmental outcomes)
Serial brain ultrasound examinations are routinely performed as standard of care after preterm birth for timely de-tection of brain hemorrhage in the first week of life and brain injury in the weeks thereafter until term equivalent age. For infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer. For infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge.
No additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Extra ultrasound images will be exported anonymized and analyses offline by two investigators independently
入排标准
- 年龄范围
- — 至 3 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infant with a gestational age below 32 0/7 weeks
- •birth weight between the 3rd and 97th percentile.
- •No cerebral Doppler abnormalities on prenatal ultrasound (i.e. brain sparing)
排除标准
- •Brain vessel anomaly
- •Major congenital malformation
- •No parental consent
- •IVH > grade 2 (Papile classification or structural brain abnormalities on the first ultrasound
- •Severe hemodynamic instability in the first 6 hours of life requiring treatment with inotropes.
研究组 & 干预措施
Preterm infants < 28 weeks gestational age
For infants born before 28 0/7 weeks, standard of care consists of brain ultrasound performed on admission, day 1, day 2, day 3, day 7, and then weekly until discharge.
干预措施: Doppler Ultrasound of venous cerebral circulation (Diagnostic Test)
Preterm infants born between 28 0/7 and 31 6/7 weeks
For infants born between 28 0/7 and 31 6/7 weeks, brain ultrasound is performed on admission, once between day 1 and 3, once between day 7 and 10, and then 2-weekly until discharge or transfer.
干预措施: Doppler Ultrasound of venous cerebral circulation (Diagnostic Test)
结局指标
主要结局
Normative values of internal cerebral vein velocity
时间窗: 2-3 years
Determination of normative values of ICV velocity and their range in the first weeks of life in stable preterm infants. The Doppler measurements will be performed at several moments after birth: day 0, 1, 2, 3, 7, 14, 21, etc untill 36 weeks gestational age. For this purpose we will calculate the Maximum velocity (cm/s), the mean velocity (cm/s) and the variability (according to Ikeda et al) of the flow pattern in the Internal Cerebral Vein. These velocities will be plotted in an attempt to discover longitudinal normative values in this cohort of 50 preterm infants.
次要结局
- Short-term outcome: cerebral complications in the neonatal phase(2-3 years)
- Long-term outcome: neurodevelopmental impairment(3-5 years)
研究者
Fleur Anne Camfferman
Principle investigator, Clinical professor
Universitair Ziekenhuis Brussel