New ultrasound technology for monitoring brain blood flow in sick newborns
NeoDoppler: New Ultrasound Technology for Continuous Monitoring of Cerebral Blood Flow in Infants
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 0 Minutes to 12 Months |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06646250 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Trondheim
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.