An observational study in Preterm, Patent Ductus Arteriosus and Sepsis, sponsored by St. Olavs Hospital. Recruiting at 1 site in Norway. Open to participants aged 0 Minutes to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by St. Olavs Hospital · Observational
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.
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:
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 180 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →St. Olavs Hospital is the lead sponsor of 171 studies on the registry; 29 are open to participants now.
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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.
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Exclusion Criteria:
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
Preterm neonates with patent ductus arteriosus (n=20)
Device: NeoDoppler - CE certified
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 such as intubation, anesthesia, spinal puncture, peripheral and central arterial and venous catheter. We will include 20-30 neonates.
Device: NeoDoppler - CE certified
Infants with infection/sepsis and/or meningitis (n=40).
Device: NeoDoppler - CE certified
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.
Cerebral Doppler velocities (cm/second)
Cerebral Doppler velocities measured in cm/sec is generated by tracing of the Doppler spectrum.
Time frame: 2 hours - 7 days
Measurement quality
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.
Time frame: 2 hours - 7 days
Plan to share: Undecided — Anonymous ultrasound data can be shared on reasonable request
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