Clinical trial NCT06646250: NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
Official title: NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preterm
Patent Ductus Arteriosus
Sepsis
Asphyxia
Stroke
Pulmonary Hypertension
Congenital Heart Disease
Keywords: Cerebral Doppler
Monitoring
Continuous
Neonate
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2024-10-17
Enrollment: 180
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates/infants born prematurely or at term that are healthy or that have a medical contentions or that are in need of procedures that are admitted to the maternal ward or neonatal intensive care at St. Olavs Hospital in Trondheim, Norway.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Cerebral Doppler velocities (cm/second)
timeFrame: 2 hours - 7 days
Secondary outcomes:
measure: Measurement quality
timeFrame: 2 hours - 7 days
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Children's clinic, St. Olavs University Hospital
Study officials:
affiliation: Childrens Clinic, St. Olavs University Hospital and NTNU
name: Siri Ann Nyrnes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology, Trondheim, Norway
name: Øyvind Rognmo, PhD
role: STUDY_DIRECTOR
References: