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

NCT06646250 | Recruiting

• 1 other identifier: 2017/314
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cerebral Doppler; Monitoring; Continuous; Neonate

Outcome Measures

Primary Outcomes (1)

• Cerebral Doppler velocities (cm/second)

  Cerebral Doppler velocities measured in cm/sec is generated by tracing of the Doppler spectrum.

  2 hours - 7 days

Secondary Outcomes (1)

• Measurement quality

  2 hours - 7 days

Study Arms (5)

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.

Device: NeoDoppler - CE certified

Patients with patent ductus arteriosus (premature infants)

Preterm neonates with patent ductus arteriosus (n=20)

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.

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.

Device: NeoDoppler - CE certified

Neonates with infection/sepsis

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

Device: NeoDoppler - CE certified

Interventions

NeoDoppler - CE certified 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.

Different groups of sick neonates; Feasibility study - Healthy neonates; Neonates with infection/sepsis; Neonates/infants undergoing procedures; Patients with patent ductus arteriosus (premature infants)

Eligibility Criteria

• Age: 0 Minutes - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Children's clinic, St. Olavs University Hospital

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Premature Birth; Ductus Arteriosus, Patent; Sepsis; Asphyxia; Stroke; Hypertension, Pulmonary; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Death; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension

Study Officials

• Siri Ann Nyrnes, MD, PhD

  Childrens Clinic, St. Olavs University Hospital and NTNU

  PRINCIPAL INVESTIGATOR

• Øyvind Rognmo, PhD

  Norwegian University of Science and Technology, Trondheim, Norway

  STUDY DIRECTOR

Central Study Contacts

Siri Ann Nyrnes, MD, PhD

CONTACT

004793062121; siri.a.nyrnes@ntnu.no

Siv Steinsmo Ødegård, MD, PhD

CONTACT

97772989; siv.steinsmo@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: October 17, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

NO (1)