Haemodynamic instability Trials in Disease

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

This clinical trial is being conducted in Spain and focuses on finding the optimal dose of a medication called dobutamine for very preterm infants experiencing haemodynamic insufficiency. This condition occurs when the heart and blood vessels cannot circulate blood effectively throughout the body, which is a serious concern for babies born before 32 weeks of pregnancy.

Main inclusion criteria: The trial is open to infants born at 32 weeks and 6 days of pregnancy or earlier who have haemodynamic insufficiency. Specifically, these infants must have blood flow through the superior vena cava (a major vein that carries blood to the heart) of less than 51 ml per kg per minute. A parent or legally designated representative must sign an informed consent form, which can be provided before birth if necessary.

Main exclusion criteria: The trial excludes newborns who do not have haemodynamic insufficiency or low blood flow through the superior vena cava. Additionally, infants who are not classified as very preterm are not eligible for this study.

Focus and goals: The primary goal of this trial is to determine the minimum effective dose of dobutamine needed to improve blood circulation in these vulnerable infants. Researchers will monitor blood flow using echocardiography (a type of heart ultrasound) at 1 and 3 hours after starting the dobutamine infusion. The target is to achieve and maintain a blood flow above 55 ml/kg/min through the superior vena cava. The study will also track how many infants maintain stable blood flow with dobutamine alone during the first 72 hours after birth, while recording any adverse events that may occur.

Investigational drug: Dobutamine is the medication being tested in this trial. It is given directly into the bloodstream through an intravenous infusion. Dobutamine works by strengthening the heart's pumping action, which helps increase the amount of blood flowing through the body. This is particularly important for very preterm infants whose hearts are often underdeveloped. The medication stimulates certain receptors in the heart, improving both the heart rate and the strength of heart contractions. By finding the right dose, researchers hope to improve blood circulation in these infants without causing unnecessary side effects.