Ongoing Clinical Trials for Premature Babies
There are currently 4 ongoing clinical trials studying treatments and care approaches for premature babies. These studies are investigating ways to prevent chronic lung disease, optimize oxygen levels at birth, and improve breathing support in extremely premature infants. Trials are being conducted across several European countries including Ireland, Spain, Hungary, and the Netherlands.
Clinical trial locations
- Finland
- Germany
- Hungary
- Ireland
- Italy
- Netherlands
- Portugal
- Spain
Study on Mecasermin Rinfabate for Preventing Chronic Lung Disease in Extremely Premature Babies
This trial is evaluating whether a new medication called Mecasermin rinfabate (also known as OHB-607) can help prevent chronic lung disease in extremely premature infants. The study focuses on babies born between 23 and 27 weeks of pregnancy, who are at particularly high risk of developing a serious lung condition called bronchopulmonary dysplasia.
Who can participate: Babies born between 23 weeks and 27 weeks and 6 days of gestational age are eligible. Parents must provide written informed consent before any study procedures begin. The birth mother must also consent to share information about her medical history, pregnancy, and the baby’s birth.
Who cannot participate: Babies with other serious health conditions that might interfere with the study, those currently in another clinical trial, or those who have had severe allergic reactions to any study medication ingredients are excluded. Other exclusions include infants whose mothers have a history of drug or alcohol abuse, uncontrolled mental health disorders, infections requiring antibiotics, recent major surgery, or a history of heart disease or stroke.
What the study involves: The medication is given as a solution through an intravenous line directly into the bloodstream. Participants are randomly assigned to receive either OHB-607 or standard neonatal care. Healthcare professionals closely monitor the babies’ health and development through regular follow-up visits and telephone calls. The study continues until the baby reaches 36 weeks postmenstrual age.
Study goal: Researchers aim to determine if OHB-607 can reduce the number of severe lung disease cases or deaths by 36 weeks of age compared to standard care alone. The study will track breathing patterns, oxygen needs, and overall growth and development of participating infants.
Study on the Effects of 30% vs. 60% Oxygen Levels at Birth for Improving Development in Premature Infants
This trial is investigating whether starting with a higher oxygen concentration (60%) compared to a lower concentration (30%) at birth can improve development outcomes in very low birthweight infants born prematurely. The study will follow infants from birth until they are 18 to 24 months old.
Who can participate: Infants born between 23 and 28 weeks of gestation are eligible. They must be designated to receive full resuscitation, meaning there is no parental request or predetermined decision to forego resuscitation efforts. Infants must have no known major birth defects or genetic disorders.
Who cannot participate: Only infants born before 37 weeks of pregnancy (premature infants) can participate. Those born at or after 37 weeks are excluded from this study.
What the study involves: The study uses medical oxygen administered through inhalation during initial resuscitation. Babies are given either 30% or 60% oxygen concentration at birth. Researchers then monitor the infants for major developmental issues, including difficulties with movement, severe learning delays, hearing problems requiring aids, and significant vision problems. The study also tracks hospital complications such as severe brain injuries, lung conditions, and eye problems.
Study goal: The main aim is to determine if there is any difference in survival rates or developmental outcomes between the two oxygen levels. The study seeks to provide valuable information on how oxygen levels at birth affect the long-term health and development of premature infants.
Study on Budesonide and Poractant Alfa for Preventing Lung Disease in Very Preterm Infants
This trial is exploring whether a combination treatment of Budesonide (an anti-inflammatory medication) and Poractant Alfa (a lung surfactant) can prevent bronchopulmonary dysplasia in very preterm infants born at or before 32 weeks of pregnancy.
Who can participate: Babies born at 32 weeks of gestation or earlier, of any birth weight, who are admitted to the Neonatal Unit are eligible. Parents or legal representatives must sign informed consent after understanding what the study involves. Both male and female babies can participate.
Who cannot participate: Newborns older than 32 weeks of pregnancy cannot participate. Babies who do not have bronchopulmonary dysplasia or were not born preterm are also excluded.
What the study involves: The combination treatment is delivered directly into the lungs through a procedure called endotracheopulmonary instillation. Budesonide reduces inflammation while Poractant Alfa helps the lungs function better by keeping air sacs open. Some infants receive the combination treatment while others receive only the surfactant. Lung health is monitored through ultrasounds on days 3, 7, 14, 21, and 28 of life, and at 36 weeks postmenstrual age. Inflammation levels are checked using specific markers in respiratory secretions.
Study goal: Researchers are assessing whether the combination treatment can prevent bronchopulmonary dysplasia and reduce the need for oxygen and respiratory support. The study also includes a neurodevelopmental assessment at 2 years of age to evaluate long-term outcomes including cognitive and motor skills, language development, and any ongoing respiratory issues.
Study on the Effect of Caffeine Citrate for Patients with Extubation Failure and Bronchopulmonary Dysplasia
This trial is testing whether giving an additional dose of Caffeine Citrate before removing a breathing tube can improve the chances of successful extubation (removal of the breathing tube) in preterm newborns at risk of breathing difficulties.
Who can participate: The study is for preterm babies born before the 32nd week of gestation who have been on a mechanical ventilator (a breathing machine) for at least 48 hours. Babies must be approaching their first planned extubation. Both male and female babies can participate.
Who cannot participate: Patients who have not experienced extubation failure (difficulty breathing after tube removal) or do not have bronchopulmonary dysplasia cannot participate. Babies outside the specified age range or not belonging to the study’s target group are also excluded.
What the study involves: An additional loading dose of Caffeine Citrate is given through an intravenous injection or infusion before removing the breathing tube. Caffeine stimulates breathing in premature babies. Researchers closely monitor whether reintubation (putting the tube back in) becomes necessary. They also track breathing pauses, side effects such as elevated heart rate and blood pressure, digestive issues, and the development of conditions like necrotizing enterocolitis (a serious intestinal disease) and brain-related complications.
Study goal: The study aims to determine if the additional caffeine dose can improve extubation success rates and reduce the need to reinsert the breathing tube. Researchers will also assess neurodevelopmental outcomes to understand the medication’s impact on overall health and development in these vulnerable infants.
Summary
These four clinical trials represent important research efforts to improve outcomes for premature babies across Europe. A notable concentration of trials is occurring in Ireland, which is participating in two separate studies. The research encompasses several key areas of neonatal care: preventing chronic lung disease, optimizing oxygen therapy at birth, and improving respiratory support strategies.
The trials are investigating different therapeutic approaches, including the novel medication Mecasermin rinfabate (OHB-607), oxygen therapy variations, a combination of Budesonide and Poractant Alfa, and Caffeine Citrate dosing strategies. Most studies focus on extremely premature infants born before 32 weeks of gestation, reflecting the particular vulnerability of this population to respiratory complications.
All trials emphasize long-term monitoring, with several following infants until 18-24 months or even 2 years of age to assess neurodevelopmental outcomes. This long-term approach recognizes that immediate survival is only one aspect of successful neonatal care, and that developmental outcomes are equally important for these vulnerable patients.