NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Cerebral Doppler velocities (cm/second)
研究概览
简要总结
Non-invasive tools for monitoring of course of disease are important and necessary in the treatment of pre-term/premature infants and sick neonates. For many years, the ultrasound group in Trondheim has been at the forefront in the development of new ultrasound technology for the diagnosis and monitoring of disease. Several methods previously developed in this research group are today widely used in hospitals around the world. In this project the investigators aim to test a new ultrasound technology that allows continuous monitoring of cerebral blood flow in sick neonates and pre-term children. This technology was CE-certified in October 2022, and in this project the investigators will test the CE-certified version with the newest available approved software.
详细描述
A new ultrasound technology called NeoDoppler has been developed, which can measure blood flow in the brain over time. The product is approved for clinical use (CE approved). A pilot study, with with inclusion of different patient groups in need of continuous monitoring, will be conducted to map variability of cerebral hemodynamics. These studies include:
- A feasibility study on healthy preterm- and term born neonates to map what is normal cerebral blood flow in neonates born before gestational week 32, in gestational week 32-37 and at term.
- A study including preterm neonates with patent ductus arteriosus to look at the connection between the heart's function and the brain's blood flow.
- Studies of sick neonates including conditions such as perinatal asphyxia, stroke, pulmonary hypertension and congenital heart disease to study how different medical conditions influences cerebral blood flow.
- A study on cerebral blood flow during ongoing procedures such as intubation, anesthesia, spinal puncture and peripheral and central arterial- and venous catheter.
- A study of how infection, sepsis and meningitis affects cerebral blood flow.
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
- 0 Minutes 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Open fontanelle
- •Healthy preterm or term born neonates
- •Neonates with a medical condition of interest according to the different cohort studies: patent ductus arteriosus, perinatal asphyxia, stroke, pulmonary hypertension, congenital heart condition or infection/sepsis/meningitis
- •Neonates in need of procedures
排除标准
- •Caregivers not understanding/speaking Norwegian or English
- •Caregivers not giving their consent
研究组 & 干预措施
Neonates with infection/sepsis
Infants with infection/sepsis and/or meningitis (n=40).
干预措施: NeoDoppler - CE certified (Device)
Feasibility study - Healthy neonates
Neonates born with gestational week < 32 weeks, gestational week 32-37 and at term. Will will include 20-30 of each sex in each group.
干预措施: NeoDoppler - CE certified (Device)
Patients with patent ductus arteriosus (premature infants)
Preterm neonates with patent ductus arteriosus (n=20)
干预措施: NeoDoppler - CE certified (Device)
Different groups of sick neonates
Neonates with different medical conditions such as perinatal asphyxia, stroke, pulmonary hypertension and congenital heart disease will be conducted. We will include 5-30 neonates in each group.
干预措施: NeoDoppler - CE certified (Device)
Neonates/infants undergoing procedures
Neonates/infants undergoing procedures such as intubation, anesthesia, spinal puncture, peripheral and central arterial and venous catheter. We will include 20-30 neonates.
干预措施: NeoDoppler - CE certified (Device)
结局指标
主要结局
Cerebral Doppler velocities (cm/second)
时间窗: 2 hours - 7 days
Cerebral Doppler velocities measured in cm/sec is generated by tracing of the Doppler spectrum.
次要结局
- Measurement quality(2 hours - 7 days)