Assistance Publique Hopitaux De Marseille
Marseille, France
Rare diseases
Investigational molecules
Locations
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying the effects of a treatment method called LISA, which stands for Less Invasive Surfactant Administration, in preterm babies who are born before 32 weeks of pregnancy and are experiencing a condition known as Respiratory Distress Syndrome. This condition affects the lungs and makes it difficult for the baby to breathe. The study will compare the use of a medication called Propofol, which is used for sedation, to a placebo during the LISA procedure. The goal is to see if using Propofol helps reduce the need for mechanical ventilation, which is a machine that helps with breathing, within the first 72 hours of the baby's life.
In addition to Propofol, the study may involve the use of another medication called Ketamine if additional sedation is needed. The trial will monitor various outcomes, including the rate of mechanical ventilation required, the comfort level of the babies during the procedure, and any potential side effects. The study will also assess the babies' health at different stages, such as at 36 weeks of gestational age and at two years old, to evaluate their development and any long-term effects.
The trial is designed to be double-blind, meaning neither the healthcare providers nor the participants will know who is receiving Propofol or the placebo, to ensure unbiased results. The study aims to provide valuable information on the best practices for treating Respiratory Distress Syndrome in preterm infants, potentially improving their care and outcomes.
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
9 criteria
8 criteria
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Marseille, France
La Tronche, France
Limoges, France
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