Ongoing Clinical Trials for Neonatal Respiratory Failure
Two clinical trials are currently investigating treatments for neonatal respiratory failure. These studies focus on improving breathing outcomes in newborns who experience difficulty breathing shortly after birth or following mechanical ventilation. The trials are taking place in Poland and Hungary, testing different approaches to support respiratory function in vulnerable newborn populations.
Clinical trial locations
- Hungary
- Poland
Study on Persistent Pulmonary Hypertension in Newborns Treated with Salbutamol and Sodium Chloride
This trial is investigating persistent pulmonary hypertension of the newborn, a condition where a baby’s circulation system does not properly adapt to breathing outside the womb, leading to high blood pressure in the lungs. This makes it difficult for the baby to get enough oxygen into their blood because the blood vessels in the lungs remain too tight.
Who can participate: The study is looking for newborns born between 32 and 42 weeks of pregnancy who experience breathing difficulties. Specifically, babies who have breathing problems such as fast breathing or difficulty breathing lasting more than 15 minutes after birth, or those requiring breathing support within the first 6 hours of life. A chest X-ray must be taken within the first 6 hours, and an acid-base balance test must be performed using blood from the umbilical cord or heel prick within the first hour of life.
Who cannot participate: Newborns are excluded if they have breathing disorders causing respiratory failure, need ventilation with oxygen levels higher than 30%, show signs of increased lung pressure on an echocardiogram, or have a difference in oxygen levels before and after the heart’s duct of more than 10%.
Study focus: The trial aims to evaluate how often persistent pulmonary hypertension occurs in newborns treated with salbutamol and to assess whether this medication can help relax blood vessels in the lungs, improve breathing, and increase oxygen levels. Researchers will monitor the need for additional oxygen, the duration of breathing support, overall hospital stay, and any adverse events. The study will continue until December 31, 2025.
Investigational treatment: Salbutamol is a medication commonly used to open up airways in the lungs, making it easier to breathe. It is administered through inhalation and works by relaxing the muscles in the airways. In this trial, it is being tested to see if it can help relax tight blood vessels in the lungs of newborns with this condition.
Study on the Effect of Caffeine Citrate for Patients with Extubation Failure and Bronchopulmonary Dysplasia
This trial examines whether giving an additional dose of caffeine citrate before removing a breathing tube can improve outcomes for premature babies at risk of extubation failure and bronchopulmonary dysplasia. Extubation failure happens when a baby has difficulty breathing on their own after being taken off a breathing machine. Bronchopulmonary dysplasia is a chronic lung condition affecting premature infants who have received oxygen therapy or mechanical ventilation.
Who can participate: The study includes preterm babies born before the 32nd week of pregnancy who have been on a mechanical ventilator for at least 48 hours and are about to have their first planned removal of the breathing tube. Both male and female babies can participate.
Who cannot participate: Babies who have not experienced extubation failure or do not have bronchopulmonary dysplasia are excluded. The study also has specific age range requirements and is designed for a particular patient group.
Study focus: The primary goal is to determine whether giving an extra loading dose of caffeine citrate before removing the breathing tube reduces the need for reintubation, which means putting the breathing tube back in. Researchers will also monitor breathing pauses, side effects such as increased heart rate and blood pressure, digestive issues, and the development of serious conditions like necrotizing enterocolitis. Brain-related conditions and long-term neurodevelopmental outcomes will also be assessed. The trial is expected to conclude by April 4, 2027.
Investigational treatment: Caffeine citrate is administered through injection and works by stimulating the central nervous system and respiratory system, enhancing breathing efforts. It is commonly used to treat apnea of prematurity and is being tested here to see if an additional dose can improve extubation success rates in vulnerable premature infants.
Summary
Two clinical trials are currently addressing different aspects of neonatal respiratory failure. One trial in Poland focuses on persistent pulmonary hypertension in newborns born between 32 and 42 weeks of pregnancy, testing whether salbutamol can help relax tight blood vessels in the lungs and improve oxygen levels. The other trial in Hungary targets premature babies born before 32 weeks who are at risk of extubation failure and bronchopulmonary dysplasia, investigating whether an additional dose of caffeine citrate can improve the success of breathing tube removal.
Both studies address critical breathing problems in newborns but target different patient populations and use different medications. The Polish study focuses on newborns with circulation adaptation problems, while the Hungarian trial addresses premature infants with chronic lung conditions. These trials represent important research efforts to improve breathing outcomes and reduce complications in vulnerable newborn populations across Central Europe.
