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Finding the Right Dose of Dobutamine for Very Preterm Infants with Heart and Blood Flow Issues

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called in very preterm infants who have a condition known as . This condition occurs when the heart and blood vessels are not able to circulate blood effectively, which can be a concern in newborns born before 32 weeks of pregnancy. The purpose of the study is to find the minimum effective dose of needed to improve blood flow in these infants.

is given as a solution through an intravenous infusion, which means it is delivered directly into the bloodstream. The study will observe how well the infants respond to different doses of by measuring the blood flow in a specific part of the body called the superior vena cava (SVC). The goal is to ensure that the blood flow is above a certain level, which indicates better circulation.

The study will monitor the infants for the first 72 hours after birth to see how well they maintain a stable blood flow with the help of . Researchers will also keep track of any side effects or adverse events that may occur during the study. This information will help determine the safest and most effective dose of for improving blood circulation in very preterm infants with .

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that the informed consent form is signed and dated by a parent or legally designated representative. This consent can be provided before birth if necessary.
Step 2
Eligibility confirmation
Eligibility is confirmed based on being born up to 32 weeks and 6 days of gestation and having a condition called haemodynamic insufficiency, which means the blood flow through the superior vena cava (SVC) is less than 51 ml/kg/min.
Step 3
Medication administration
The medication used in this study is called dobutamine. It is administered as a solution through a vein, a process known as intravenous perfusion.
The goal is to find the minimum effective dose of dobutamine needed to improve blood flow in very preterm infants.
Step 4
Monitoring and assessment
Blood flow is monitored using an echocardiogram, a type of ultrasound for the heart, at 1 and 3 hours after the dobutamine infusion begins.
The primary aim is to achieve and maintain an SVC flow above 55 ml/kg/min.
Step 5
Ongoing evaluation
The study also evaluates the proportion of infants who maintain a stable blood flow status with dobutamine alone within the first 72 hours after birth.
Any adverse events, which are unexpected medical issues, are recorded and compared.

Who can join the trial?

3 criteria

Born up to 32 weeks and 6 days of pregnancy.
Has haemodynamic insufficiency, which means the heart is not pumping blood effectively. This is defined as having a SVC flow (blood flow through a major vein) of less than 51 ml per kg per minute.
A signed and dated informed consent form must be provided by the father, mother, or legally designated representative. This consent can be given before birth as described in the study details.

Who cannot join the trial?

3 criteria

Patients who are not newborns with hemodynamic insufficiency. This means the heart and blood vessels are not working well enough to supply the body with the blood it needs.
Patients who do not have low SVC flow. SVC stands for Superior Vena Cava, a large vein that carries blood to the heart. Low flow means not enough blood is moving through this vein.
Patients who are not very preterm infants. Very preterm means babies born much earlier than the usual 40 weeks of pregnancy.

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Verified sites

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Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcon, Spain

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Investigated drugs

Dobutamine is a medication used in this clinical trial to help improve blood flow in very preterm infants. It works by strengthening the heart's pumping action, which can help increase the amount of blood that flows through the body. In this study, researchers are trying to find the smallest amount of dobutamine that is effective in treating low blood flow in these infants. This is important because very preterm infants often have underdeveloped hearts, and improving their blood flow can be crucial for their health and development. The goal is to determine the right dose that helps the infants without causing unnecessary side effects.

Dobutamine

What is already known about the treatment

Dobutamine – Dobutamine is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials to determine the best dose for treating very preterm infants with low blood flow in their bodies. The main use of dobutamine is to help improve heart function and blood circulation in newborns who have trouble with their blood flow. At the molecular level, dobutamine works by stimulating certain receptors in the heart, which helps the heart pump more effectively. It is classified as a cardiovascular drug, specifically a type of medication known as a beta-agonist, which helps to increase heart rate and strength of heart contractions.

Investigated diseases

Hemodynamic Insufficiency in Neonates – Hemodynamic insufficiency in neonates refers to the inadequate blood flow and circulation in newborns, particularly affecting very preterm infants. This condition can lead to insufficient delivery of oxygen and nutrients to vital organs. It often manifests as low systemic vascular resistance and reduced cardiac output. The progression involves potential organ dysfunction due to inadequate perfusion. Monitoring and managing blood flow and pressure are crucial to prevent further complications. The condition requires careful observation to ensure that the neonate maintains a stable hemodynamic status.