Study on Newborn Brain Conditions Using Sulfur Hexafluoride Ultrasound for Babies with Hypoxic-Ischemic Injury, Stroke, or Infections
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial focuses on newborn babies with certain brain conditions. The study is looking at diseases that affect the brain's blood flow, such as hypoxic-ischemic brain injury, which occurs when the brain doesn't get enough oxygen, and brain infections. It also includes babies who have had a stroke or other brain issues like bleeding in the brain or hydrocephalus, which is a condition where fluid builds up in the brain. The trial will use a special imaging technique called contrast-enhanced ultrasound to see how well blood is flowing in the brain and how elastic the brain tissue is. The contrast used in this study is called SonoVue, which contains a substance known as sulfur hexafluoride.
The purpose of the study is to understand how these brain conditions affect blood flow and tissue elasticity in newborns during their first days of life. The study will involve giving the babies an injection of the contrast agent and then using ultrasound to take images of their brains. This will help doctors see how the blood is moving through the brain and how the brain tissue responds. The study will include babies who are full-term, those who have experienced a lack of oxygen at birth, those who have had a stroke, and those born prematurely.
Throughout the study, the babies will be monitored closely, and the imaging will be done in a safe and controlled environment. The study aims to gather important information that could help improve the understanding and treatment of these serious brain conditions in newborns. The trial will last for a period of up to 14 days for each baby, and the results will help doctors learn more about how these conditions affect the brain and how treatments can be improved in the future.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
12 criteria
- Babies born between 37 weeks and 42 weeks of pregnancy who are in the newborn intensive care unit and have a small tube (called a cannula) placed in a vein for medical reasons.
- Babies with an Apgar score of 8 or more at one and five minutes after birth. The Apgar score is a quick test done on a baby at 1 and 5 minutes after birth to see how well the baby is doing outside the mother's womb.
- Babies with a blood pH value greater than 7.15. pH is a measure of how acidic or basic the blood is.
- Babies with a birth weight between -2 and +2 standard deviations, meaning their weight is within a normal range for their age.
- The mother did not have diabetes requiring medication during pregnancy.
- No known brain disease or brain infection at birth or at the time of the study.
- Babies suffering from hypoxic-ischemic brain injury or asphyxia, which are conditions related to a lack of oxygen.
- Babies who have started cooling treatment or meet the criteria for cooling treatment due to asphyxia, even if the treatment has not started.
- Babies who do not meet the cooling treatment criteria but have an Apgar score of 7 or less at 1 minute after birth and a blood pH of less than 7.10.
- Babies diagnosed with a brain infarction, which is a type of stroke.
- Premature babies born before 37 weeks of pregnancy who are scheduled for a brain MRI around their due date. An MRI is a type of scan that uses magnets and radio waves to take pictures of the inside of the body.
- Babies with other brain conditions like brain infections, brain bleeding, or hydrocephalus, which is a condition where there is too much fluid in the brain.
Who cannot join the trial?
7 criteria
- Patients with severe congenital malformations (serious birth defects) that affect the brain.
- Patients with genetic disorders known to affect brain development.
- Patients with severe infections that are not related to the brain.
- Patients who have had major surgery within the first days of life.
- Patients with unstable vital signs (such as heart rate, breathing, or blood pressure) that cannot be controlled.
- Patients who are not expected to survive beyond the first week of life.
- Patients whose parents or guardians do not give permission for participation in the study.
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Investigated drugs
What is already known about the treatment
Investigated diseases
Neonatal Hypoxic-Ischemic Encephalopathy
This condition occurs when a newborn's brain does not receive enough oxygen and blood. It can happen during birth or shortly after. The lack of oxygen can cause brain cells to become damaged or die. Initially, the baby may appear lethargic, have difficulty breathing, or show abnormal reflexes. Over time, the brain may swell, leading to further complications. The progression can vary, with some infants showing improvement while others may develop long-term neurological issues.
Neonatal Stroke
This condition involves a disruption of blood flow to a part of a newborn's brain, leading to brain cell damage. It can occur due to a clot or bleeding in the brain. Symptoms may include seizures, difficulty feeding, or reduced movement on one side of the body. As the condition progresses, some infants may develop motor or cognitive challenges. The extent of these challenges can vary widely. Early intervention can help manage some of the developmental issues.
Neonatal Central Nervous System Infections
These infections affect the brain and spinal cord of newborns. They can be caused by bacteria, viruses, or other pathogens. Symptoms may include fever, irritability, poor feeding, or seizures. As the infection progresses, it can lead to inflammation and damage to brain tissues. The severity and outcomes depend on the type of infection and the timeliness of intervention. Long-term effects can include developmental delays or neurological deficits.
Former Preterm Infants at Term
These are infants born prematurely but assessed at their expected full-term date. They may have experienced complications due to early birth, affecting their development. Initially, they might have difficulties with feeding, breathing, or maintaining body temperature. Over time, they may face challenges in growth and neurological development. Monitoring and support are crucial to address any emerging issues. The progression varies, with some infants catching up to their peers while others may need ongoing support.
Other Neonatal Brain Pathologies
This category includes various conditions affecting the newborn brain, not limited to specific diseases. These can involve structural abnormalities, metabolic disorders, or other unspecified issues. Symptoms and progression depend on the specific pathology. Some conditions may present with seizures, developmental delays, or feeding difficulties. The impact on the infant's development can vary widely. Early detection and management are important to address potential complications.
sourced from the EU Clinical Trials Register and site verification
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