Ongoing Clinical Trials for Neonatal Anoxia
Currently, there is 1 ongoing clinical trial investigating brain conditions in newborns affected by oxygen deprivation and related complications. This trial is exploring advanced imaging techniques to better understand how these conditions affect blood flow and brain tissue in the early days of life.
Clinical trial locations
Study on Newborn Brain Conditions Using Sulfur Hexafluoride Ultrasound for Babies with Hypoxic-Ischemic Injury, Stroke, or Infections
This trial is being conducted in Finland and focuses on newborn babies who have experienced various brain conditions related to oxygen deprivation, stroke, or infections. The study uses a special imaging technique called contrast-enhanced ultrasound to examine how blood flows through the brain and to assess the elasticity of brain tissue.
Main inclusion criteria:
- Babies born between 37 and 42 weeks of pregnancy who are in the newborn intensive care unit with an intravenous cannula already in place for medical reasons
- Babies with good Apgar scores (8 or more at one and five minutes after birth) and blood pH levels above 7.15, with normal birth weight
- Babies suffering from hypoxic-ischemic brain injury or asphyxia (conditions related to lack of oxygen)
- Babies who have started or meet criteria for cooling treatment due to oxygen deprivation, or those with lower Apgar scores and blood pH levels
- Babies diagnosed with brain infarction (a type of stroke)
- Premature babies born before 37 weeks who are scheduled for a brain MRI around their due date
- Babies with other brain conditions such as infections, bleeding in the brain, or hydrocephalus (fluid buildup in the brain)
Main exclusion criteria:
- Babies with severe birth defects affecting the brain
- Babies with genetic disorders known to affect brain development
- Babies with severe non-brain infections or those who have had major surgery in the first days of life
- Babies with unstable vital signs that cannot be controlled
- Babies not expected to survive beyond the first week of life
- Cases where parents or guardians do not give permission for participation
Focus and goal of the trial:
The study aims to understand how brain conditions affect blood flow and tissue elasticity in newborns during their first days of life. The trial involves admitting babies to the neonatal intensive care unit, performing an initial health assessment, and inserting an intravenous cannula if not already present. Babies will receive an injection of the contrast agent and undergo ultrasound and elastography imaging to assess brain blood flow and elasticity. Throughout the 14-day study period, babies will be closely monitored, with follow-up assessments to gather data on how these conditions affect the brain.
Investigational drug:
The trial uses SonoVue, a contrast agent containing sulfur hexafluoride. This medication is administered as a single dose directly into the vein to enhance ultrasound images of the brain, allowing doctors to better visualize blood flow patterns and tissue characteristics.
Summary
Currently, there is one active clinical trial addressing neonatal anoxia and related brain conditions in newborns. This trial is taking place in Finland and represents an important effort to improve understanding of how oxygen deprivation and related complications affect the developing brain. The study focuses on using advanced imaging technology with contrast enhancement to provide detailed information about brain blood flow and tissue properties in affected newborns.
The trial is notable for its broad inclusion of various brain conditions related to oxygen deprivation, including hypoxic-ischemic injury, stroke, brain infections, and complications in premature infants. By using SonoVue contrast-enhanced ultrasound alongside elastography, researchers hope to gather crucial information that could improve diagnosis and treatment approaches for these serious conditions in the future.