Ongoing Clinical Trials for Bronchopulmonary Dysplasia
There are currently 7 clinical trials investigating new treatments and approaches for bronchopulmonary dysplasia, a serious lung condition affecting premature infants. These studies are being conducted across multiple European countries and explore various therapies including stem cell treatments, medications, and advanced oxygen delivery systems aimed at preventing or reducing the severity of this condition in vulnerable preterm babies.
Clinical trial locations
- Belgium
- Finland
- Germany
- Hungary
- Ireland
- Italy
- Netherlands
- Portugal
- Spain
- Safety Study of Mesenchymal Cells for Preterm Infants with Bronchopulmonary Dysplasia
- Study on Budesonide and Poractant Alfa for Preventing Lung Disease in Very Preterm Infants
- Study on Mecasermin Rinfabate for Preventing Chronic Lung Disease in Extremely Premature Babies
- Study to Test if Zelpultide Alfa Helps Prevent Lung Disease in High-Risk Premature Babies
Safety Study of Mesenchymal Cells for Preterm Infants with Bronchopulmonary Dysplasia
This trial is investigating the use of special stem cells from umbilical cords to help premature babies with lung problems. The study focuses on whether this treatment is safe for these vulnerable infants.
Who can participate: The trial is looking for newborns who weigh 1,250 grams or less and were born at 28 weeks of pregnancy or earlier. The baby must be on breathing support and need an oxygen level of 0.3 or higher between days 5 and 14 of life. Both male and female infants can participate.
Who cannot participate: Babies who were not born prematurely, do not have the lung condition, are older than 28 weeks gestational age, or weigh more than 1,250 grams at birth cannot join the study.
What the study involves: The trial uses expanded allogeneic fetal umbilical cord stem mesenchymal cells, known as UC-MSC. These cells are given through repeated intravenous infusions at a dose of 5 million cells per kilogram of the baby’s weight. The main goal is to assess the safety of this treatment and monitor for any side effects. Researchers will also evaluate the baby’s lung condition, check inflammation markers, and track overall development throughout the treatment period, which can last up to six weeks.
Treatment being tested: UC-MSC is a cell-based therapy derived from umbilical cord tissue. These stem cells are believed to help by modulating the immune response and promoting tissue regeneration in the developing lungs.
Study on Mecasermin Rinfabate for Preventing Chronic Lung Disease in Extremely Premature Babies
This study is evaluating a new treatment called Mecasermin rinfabate, also known as OHB-607, to see if it can prevent severe lung disease in extremely premature babies. The treatment is given through an infusion directly into the bloodstream.
Who can participate: Written consent from the baby’s parents must be obtained before any study procedures begin. The baby must be between 23 weeks and 27 weeks and 6 days of gestational age.
Who cannot participate: Babies with other serious health conditions that might interfere with the study, those currently in another clinical trial, babies with severe allergies to study medication ingredients, those unable to follow study procedures, pregnant or breastfeeding mothers, patients with a history of substance abuse, poorly controlled mental health disorders, active infections requiring antibiotics, recent major surgery, or a history of heart disease or stroke.
What the study involves: Participants are randomly assigned to receive either OHB-607 or standard neonatal care. The medication is given as a solution through an IV line. Babies are closely monitored throughout the study with regular follow-up visits and telephone calls to track health and development until they reach 36 weeks postmenstrual age.
Treatment being tested: OHB-607 is an investigational drug being studied in a Phase 2b trial. It aims to reduce the number of severe cases or prevent death in premature babies with lung disease compared to standard care.
Study on the Safety and Effect of EXOB-001 in Preventing Bronchopulmonary Dysplasia in Extremely Preterm Newborns
This trial examines EXOB-001, a treatment made from special particles derived from umbilical cord cells called extracellular vesicles. The study aims to determine if this treatment can prevent lung disease in extremely preterm newborns.
Who can participate: The trial includes newborns from birth up to 10 days old, born between 23 and 28 weeks of pregnancy, with a birth weight between 500 and 1,500 grams. The baby must be on a breathing tube and receiving mechanical ventilation with oxygen levels greater than 25% between 3 and 10 days after birth. Written permission from parents or a legally authorized representative is required.
Who cannot participate: Babies with a previous history of the condition, those outside the specified age range, those not meeting gender criteria, or those considered part of a vulnerable population beyond the study’s scope.
What the study involves: The trial has two phases. Phase I focuses on assessing the safety of EXOB-001 when given directly into the windpipe, with monitoring for side effects until 36 weeks postmenstrual age. Phase II is a randomized study comparing EXOB-001 to a saline solution to see how well the treatment reduces lung disease severity. Monitoring includes clinical examinations, blood tests, lung ultrasounds, chest X-rays, and heart assessments.
Treatment being tested: EXOB-001 consists of extracellular vesicles from umbilical cord cells, believed to have properties that help protect developing lungs. The treatment is administered directly into the windpipe.
Study on Budesonide and Poractant Alfa for Preventing Lung Disease in Very Preterm Infants
This study explores whether combining Budesonide, an anti-inflammatory medication, with Poractant Alfa, a lung surfactant, can help prevent lung disease in very preterm infants born at or before 32 weeks of gestation.
Who can participate: The trial is for babies born at 32 weeks of pregnancy or earlier, with any birth weight, who are admitted to the Neonatal Unit. Parents or legal representatives must sign informed consent. Both male and female babies can participate.
Who cannot participate: Newborns older than 32 weeks of pregnancy, those without the lung condition, and those who were not born preterm.
What the study involves: The combination treatment is delivered directly into the lungs through a procedure called endotracheopulmonary instillation. The study monitors lung health using ultrasounds at various points and measures inflammation markers. Assessments continue through 36 weeks postmenstrual age or before discharge, with long-term follow-up at 2 years of age to evaluate brain development and respiratory health.
Treatment being tested: Budesonide is a corticosteroid that reduces lung inflammation, while Poractant Alfa is a surfactant that helps lungs function better by keeping air sacs open. The combination is administered directly into the trachea to improve breathing.
Study on the Effect of Caffeine Citrate for Patients with Extubation Failure and Bronchopulmonary Dysplasia
This trial investigates whether giving an extra dose of caffeine citrate before removing a breathing tube can improve the chances of babies breathing successfully on their own.
Who can participate: The study includes preterm babies born before the 32nd week of gestation who have been on a mechanical ventilator for at least 48 hours and are about to have their first planned extubation. Both male and female babies can participate.
Who cannot participate: Patients who have not experienced difficulty breathing after tube removal, do not have the lung condition, are outside the specified age range, do not belong to the specified clinical trial group, are not male or female, or are not considered part of a vulnerable population.
What the study involves: An additional loading dose of caffeine citrate is given through an IV injection or infusion before the breathing tube is removed. The study monitors whether reintubation is needed, the frequency of breathing pauses, side effects like elevated heart rate and blood pressure, digestive issues, and other complications. Neurodevelopmental outcomes are also assessed.
Treatment being tested: Caffeine citrate is a central nervous system stimulant that helps stimulate breathing in premature babies. The study explores if an extra dose can improve extubation success.
Study to Test if Zelpultide Alfa Helps Prevent Lung Disease in High-Risk Premature Babies
This trial studies zelpultide alfa, also known as AT-100, a protein similar to a natural lung substance called recombinant human surfactant protein-D. The study aims to see if adding this treatment to usual care can help protect lungs and prevent injury in high-risk premature infants.
Who can participate: The trial includes very premature babies born between 23 weeks and 27 weeks and 6 days of gestation who have received at least one dose of pulmonary surfactant after birth and are on invasive mechanical ventilation. Parents or legal guardians must provide written consent.
Who cannot participate: Babies who are not born prematurely, are not at high risk for developing the lung condition, are outside the specified age range, or do not meet the study’s health and safety requirements.
What the study involves: Zelpultide alfa is administered through endotracheopulmonary instillation, delivered directly into the lungs. The first dose is given at least 15 minutes after the usual lung treatment but within 96 hours of birth and within 48 hours from starting the breathing machine. The study monitors for lung disease development and other health concerns, with the main goal of preventing the condition or reducing death risk by 36 weeks of corrected age.
Treatment being tested: Zelpultide alfa is a biologic agent currently in Phase 3 clinical trials. It works at the molecular level by modulating inflammatory pathways that contribute to lung damage in preterm infants.
Study on Automatic Oxygen Control for Extremely Preterm Infants Using Oxygen PH.EUR.
This trial compares a new automatic system that adjusts oxygen levels with the traditional manual method for extremely preterm infants born between 23 and 27 weeks of pregnancy. The goal is to see if automatic control can improve health outcomes.
Who can participate: Babies born between 23 weeks and 0 days and 27 weeks and 6 days of pregnancy. Both male and female babies can participate, and the study includes infants who are considered a vulnerable population.
Who cannot participate: The exclusion criteria were not detailed in the provided information.
What the study involves: After birth and initial assessment, infants are randomly assigned to receive either closed-loop automatic control of oxygen levels or manual adjustments. Oxygen therapy is delivered through standard infant ventilators throughout the hospital stay. The study monitors for complications like severe retinopathy of prematurity, chronic lung disease, and necrotizing enterocolitis. A follow-up assessment at 24 months evaluates neurodevelopmental outcomes including motor abilities, language and cognitive development, and sensory impairments.
Treatment being tested: The closed-loop automatic control system, known as FiO2-C, automatically adjusts the amount of oxygen that infants receive during mechanical ventilation or other respiratory support, maintaining proper blood oxygen levels without constant manual adjustments.
Summary
The 7 ongoing clinical trials for bronchopulmonary dysplasia demonstrate a diverse range of innovative approaches to preventing and treating this serious lung condition in premature infants. The trials are spread across several European countries, with Spain, Italy, and Germany showing the strongest concentration of research activity.
Several notable patterns emerge from these studies. First, there is significant interest in cell-based therapies, with two trials investigating stem cells and extracellular vesicles derived from umbilical cord tissue. Second, multiple studies focus on optimizing existing treatments, such as surfactant therapy combined with anti-inflammatory medications or caffeine citrate dosing. Third, there is exploration of entirely new biological agents like Mecasermin rinfabate and zelpultide alfa, as well as technological innovations like automatic oxygen control systems.
The trials target different gestational age groups and severity levels, from extremely premature infants born as early as 23 weeks to those born up to 32 weeks. This comprehensive approach reflects the complexity of the condition and the need for tailored interventions based on the degree of prematurity and individual risk factors.
Most studies include long-term follow-up assessments extending to 24 months of age, recognizing that the impact of these interventions on neurodevelopmental outcomes is as important as immediate lung health. The emphasis on safety evaluation across all trials underscores the vulnerable nature of this patient population and the careful balance required when testing new treatments in premature infants.
