NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot

Официальное название

NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants

Обзор

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.

Подробное описание

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:

1. 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. 2. 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. 3. 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. 4. A study on cerebral blood flow during ongoing procedures such as intubation, anesthesia, spinal puncture and peripheral and central arterial- and venous catheter. 5. A study of how infection, sepsis and meningitis affects cerebral blood flow.

Вмешательства

• Устройство NeoDoppler - CE certified
  The NeoDoppler is small and light weighed constructed as a single element transducer, that can be gently fixed over the fontanelle. The system is fully compatible for cooccurring use with other intensive care equipment for neonates as well as caregiving from the parents. It is capable of measuring cerebral blood flow at different depths of the brain simultaneously. The Doppler velocity measurements arise from a cylindrical volume of tissue. It is therefore less sensitive to the exact position an

Первичные конечные точки

• Cerebral Doppler velocities (cm/second) [Срок оценки: 2 hours - 7 days]

Вторичные конечные точки (1)

• Measurement quality [Срок оценки: 2 hours - 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Caregivers not understanding/speaking Norwegian or English
• Caregivers not giving their consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Норвегия · 1 центр

• Children's clinic, St. Olavs University Hospital — Trondheim

Идентификаторы

NCT: NCT06646250 · 2017/314

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗