Neonatal respiratory distress syndrome – European Clinical Trials Information Network

Comparing 1-Minute and 5-Minute Poractant Alfa Treatment for Respiratory Distress Syndrome in Very Premature Babies Born Before 28 Weeks

Wed, 29 Apr 2026 15:08:36 +0000

This study looks at neonatal respiratory distress syndrome, which is a breathing problem that can occur in babies born very early, before their lungs are fully developed. The study uses a treatment called poractant alfa, which is a type of lung medicine known as surfactant. Surfactant is a natural substance that helps keep the air sacs in the lungs open so babies can breathe more easily. When babies are born too early, their lungs may not make enough of this substance on their own, which makes breathing difficult. The medicine is given directly into the lungs through a thin tube using a method called LISA, which stands for less invasive surfactant administration.

The purpose of the study is to find out whether the length of time it takes to give the surfactant medicine affects how well very premature babies maintain their vital signs, such as oxygen levels in the blood, heart rate, and oxygen levels in the brain. The study will compare two different ways of giving the medicine: one group will receive it over one minute, and another group will receive it over five minutes. Doctors want to see if one method works better than the other in keeping these important body measurements stable. The babies in this study are born at less than 28 weeks of pregnancy, which means they are very premature and need special care in the first days after birth.

During the study, babies will be watched closely for the first three hours after receiving the surfactant treatment, and then continuing observations will be made during their hospital stay. The medical team will measure things like oxygen levels, heart rate, and blood pressure to see how the babies respond to the treatment. They will also check whether babies need extra oxygen, whether they experience any drops in heart rate or oxygen levels, and whether they need a second dose of surfactant. The study will also look at whether babies need help from a breathing machine in the first two days after treatment and will follow their overall health until they go home from the hospital or reach their original due date, whichever comes first.

Study on the Effects of Propofol Sedation in Preterm Babies with Respiratory Distress Syndrome During LISA Procedure

Wed, 29 Apr 2026 15:02:31 +0000

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.

Study comparing prophylactic versus selective surfactant (poractant alfa, phospholipid fraction) administration in preterm infants with respiratory distress syndrome aged 25-30 weeks

Wed, 29 Apr 2026 15:01:12 +0000

This clinical trial focuses on studying Respiratory Distress Syndrome in preterm infants. The study compares two different approaches to administering surfactant medications – Alveofact and Curosurf – which are substances that help babies breathe more easily by keeping their lung air sacs open. The purpose is to determine if giving surfactant preventively works better than giving it only when needed, using a technique called Less Invasive Surfactant Administration.

The medications used in this study contain natural substances similar to those normally found in the lungs. Poractant alfa (Curosurf) and phospholipid fraction (Alveofact) are given directly into the breathing tubes of the lungs. These treatments are specifically designed for premature babies whose lungs are not fully developed at birth.

The study will follow the development of premature babies from birth until they reach 5 years of age. During this time, doctors will monitor how well the children can breathe and how their lungs develop. The main focus will be on measuring how well these children can exhale air from their lungs when they reach the age of 5 years.

Study on Phospholipid Fraction from Porcine Lung for Premature Infants with Respiratory Distress Syndrome (RDS)

Wed, 29 Apr 2026 14:27:59 +0000

This clinical trial focuses on studying a condition known as Respiratory Distress Syndrome (RDS) in premature infants. RDS is a breathing disorder that affects newborns, particularly those born before their lungs have fully developed. The treatment being tested in this study is called Curosurf, which is a type of medication known as an exogenous surfactant. This medication is made from a substance called phospholipid fraction, porcine lung, which helps the lungs function better by reducing surface tension, making it easier for the baby to breathe.

The purpose of the study is to compare two different ways of giving this surfactant to premature babies with RDS. One method uses lung ultrasonography, a technique that uses sound waves to create images of the lungs, to decide when to give the surfactant. The other method follows current medical guidelines. The study aims to see which method is more effective in reducing the need for intubation, a procedure where a tube is placed into the windpipe to help with breathing, during the first 72 hours of life.

Participants in the study will be randomly assigned to one of the two treatment groups. The study is designed to be single-blind, meaning that the healthcare providers know which treatment the baby is receiving, but the parents do not. The trial will monitor the babies closely to see how well they respond to the treatment and to ensure their safety. The goal is to find the best way to help premature infants with RDS breathe more easily and reduce the need for more invasive procedures.