NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Circulation Pilot (CE-NeoDoppler)

St. Olavs Hospital

Status: Enrolling

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

Treatments: Device: NeoDoppler - CE certified

Study type: Observational

Funder types: Other

Identifiers

NCT06646250

2017/314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 5 patient groups

Feasibility study - Healthy neonates

Description:

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.

Treatment:

Device: NeoDoppler - CE certified

Patients with patent ductus arteriosus (premature infants)

Description:

Preterm neonates with patent ductus arteriosus (n=20)

Treatment:

Device: NeoDoppler - CE certified

Different groups of sick neonates

Description:

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.

Treatment:

Device: NeoDoppler - CE certified

Neonates/infants undergoing procedures

Description:

Neonates/infants undergoing procedures such as intubation, anesthesia, spinal puncture, peripheral and central arterial and venous catheter. We will include 20-30 neonates.

Treatment:

Device: NeoDoppler - CE certified

Neonates with infection/sepsis

Description:

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

Treatment:

Device: NeoDoppler - CE certified