Clinical trial Recruiting at 1 site Observational Ages 0 Minutes to 12 Months

New ultrasound technology for monitoring brain blood flow in sick newborns

Official title: NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants

Run by St. Olavs Hospital · NCT06646250 · Data updated 2026-11-12

This study is testing a new ultrasound technology to see if it can help monitor blood flow in the brains of sick newborns and preterm infants.

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Quick facts

Study typeObservational
Ages0 Minutes to 12 Months
SexAll
Enrollment180 (estimated)
SponsorSt. Olavs Hospital
Academic / other
Locations1 site (Trondheim)
StatusRecruiting
StartedOctober 20, 2024
Main results expectedDecember 31, 2028
Study endsDecember 31, 2029
Registry record updatedApril 23, 2026
Trial IDNCT06646250 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are preterm or term neonates with open fontanelles who are either healthy or have specific medical conditions requiring continuous monitoring.

Probably not a fit

Patients whose caregivers do not understand or speak Norwegian or English, or who do not provide consent, will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate a new ultrasound technology called NeoDoppler, which allows for continuous monitoring of cerebral blood flow in sick neonates and pre-term infants. The study will include various patient groups, including healthy preterm and term neonates, as well as those with specific medical conditions such as patent ductus arteriosus, perinatal asphyxia, and stroke. The goal is to map normal cerebral blood flow and understand how different medical conditions and procedures affect cerebral hemodynamics. The technology has been CE-certified and will be tested with the latest approved software.

Why it matters

Potential benefit: If successful, this technology could significantly improve the monitoring and management of cerebral circulation in vulnerable neonates, leading to better clinical outcomes.

How similar studies have gone: Other studies have shown success with similar ultrasound monitoring approaches, but this specific technology is novel in its application for continuous cerebral blood flow monitoring in neonates.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Children's clinic, St. Olavs University Hospital
    Trondheim, Norway
    Recruiting

Study contacts

  • Principal investigator: Siri Ann Nyrnes, MD, PhD — Childrens Clinic, St. Olavs University Hospital and NTNU
  • Study coordinator: Siri Ann Nyrnes, MD, PhD
  • Email: siri.a.nyrnes@ntnu.no
  • Phone: 004793062121

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.