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

Recruiting

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

• Registration Number: NCT06646250
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-17
• Study Start: 2024-10-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2028-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral Doppler velocities (cm/second)	2 hours - 7 days	Cerebral Doppler velocities measured in cm/sec is generated by tracing of the Doppler spectrum.

Secondary Outcome Measures

Name	Time	Method
Measurement quality	2 hours - 7 days	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.

Trial Locations

Locations (1)

Children's clinic, St. Olavs University Hospital; 🇳🇴 Trondheim, Norway