PretermCE-NeoDopplerNCT06646250
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot
An observational study of Preterm and Patent Ductus Arteriosus, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 minutes to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterm, Patent Ductus Arteriosus, Sepsis
- What is being tested?
- NeoDoppler - CE certified
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- 20 Oct 2024to 31 Dec 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 minutes to 12 months
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- Caregivers not understanding/speaking Norwegian or English
- Caregivers not giving their consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Children's clinic, St. Olavs University Hospital
Trondheim, 7030
Siri Ann Nyrnes, MD, PhD, +4793062121, siri.ann.nyrnes@stolav.no
Ragnhild Støen, MD, PhD, +4799565665, Ragnhild.Stoen@stolav.no
About this study
Official title: NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants
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.
Read the 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:
- 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.
- Conditions
- Preterm, Patent Ductus Arteriosus, Sepsis, Asphyxia, Stroke, Pulmonary Hypertension
- Being tested
- NeoDoppler - CE certified
- Keywords
- Cerebral Doppler, Monitoring, Continuous, Neonate
- Medical subject headings
- Premature Birth, Ductus Arteriosus, Patent, Sepsis, Asphyxia, Stroke, Hypertension, Pulmonary, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoDoppler - CE certifiedDevice
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 and angle of the probe over the fontanel to target the vessels of interest than standard hand-held Doppler. This means that the NeoDoppler system may be placed by healthcare professionals who do not have specialized training performing diagnostic ultrasound exams of the cerebral vasculature in neonates.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: NeoDoppler - CE certified | |
| Patients with patent ductus arteriosus (premature infants) | Preterm neonates with patent ductus arteriosus (n=20) Receives: Device: NeoDoppler - CE certified | |
| 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. Receives: Device: NeoDoppler - CE certified | |
| 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. Receives: Device: NeoDoppler - CE certified | |
| Neonates with infection/sepsis | Infants with infection/sepsis and/or meningitis (n=40). Receives: Device: NeoDoppler - CE certified |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Doppler velocities (cm/second)
Cerebral Doppler velocities measured in cm/sec is generated by tracing of the Doppler spectrum.
Measured: 2 hours - 7 days
Secondary outcomes (1)
Measurement quality
Quality indicator:
Defined as a scale from 0-100% where 100% is the best possible Doppler spectrum quality. Values below 80% is below the threshold of good enough quality to be used as valid measurements in the study.
Measured: 2 hours - 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start20 Oct 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Siri Ann Nyrnes, MD, PhD, Principal investigator, Childrens Clinic, St. Olavs University Hospital and NTNUØyvind Rognmo, PhD, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06646250
- Sponsor's protocol ID
- 2017/314
- Acronym
- CE-NeoDoppler
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous ultrasound data can be shared on reasonable request