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

NCT ID: NCT06646250

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2029-12-31

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.

Conditions

Preterm; Patent Ductus Arteriosus; Sepsis; Asphyxia; Stroke; Pulmonary Hypertension; Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

NeoDoppler - CE certified

Intervention Type: DEVICE

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.

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.

NeoDoppler - CE certified

Intervention Type: DEVICE

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.

Neonates with infection/sepsis

Infants with infection/sepsis and/or meningitis (n=40).

NeoDoppler - CE certified

Intervention Type: DEVICE

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.

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.

NeoDoppler - CE certified

Intervention Type: DEVICE

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.

Patients with patent ductus arteriosus (premature infants)

Preterm neonates with patent ductus arteriosus (n=20)

NeoDoppler - CE certified

Intervention Type: DEVICE

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.

Interventions

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 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 0 Minutes
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siri Ann Nyrnes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Childrens Clinic, St. Olavs University Hospital and NTNU

Øyvind Rognmo, PhD

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology, Trondheim, Norway

Locations

Children's clinic, St. Olavs University Hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Siri Ann Nyrnes, MD, PhD

Role: CONTACT

siri.a.nyrnes@ntnu.no

004793062121

Siv Steinsmo Ødegård, MD, PhD

Role: CONTACT

siv.steinsmo@gmail.com

97772989 ext. 0047

Facility Contacts

Siri Ann Nyrnes, MD, PhD

Role: primary

siri.ann.nyrnes@stolav.no

+4793062121

Ragnhild Støen, MD, PhD

Role: backup

Ragnhild.Stoen@stolav.no

+4799565665

Other Identifiers

2017/314

Identifier Type: -

Identifier Source: org_study_id