Ongoing Clinical Trials for Neonatal Respiratory Distress Syndrome
Three clinical trials are currently investigating treatments for respiratory distress syndrome in premature infants across Spain, Germany, and France. These studies focus on surfactant administration techniques and sedation methods to improve breathing outcomes in preterm babies.
Clinical trial locations
- France
- Germany
- Spain
Study comparing prophylactic versus selective surfactant (poractant alfa, phospholipid fraction) administration in preterm infants with respiratory distress syndrome aged 25-30 weeks
This trial compares two approaches to administering surfactant medications in premature babies: giving it preventively versus only when needed. The study follows children from birth until they reach 5 years of age, monitoring their breathing and lung development.
Inclusion criteria: The trial accepts premature babies born between 25 and 30 weeks plus 6 days of pregnancy who are less than 60 minutes old. Babies must be able to breathe on their own while using CPAP breathing support, with oxygen levels at least 90% while receiving no more than 30% oxygen. Parents or legal guardians must provide written consent, which can be obtained after enrollment if necessary. Both male and female infants can participate.
Exclusion criteria: The trial excludes infants born before 25 weeks or after 30 weeks and 6 days of pregnancy, those with major birth defects, infants who have already received surfactant treatment, and those with severe respiratory failure requiring immediate mechanical ventilation. Babies whose parents haven’t provided consent, those with genetic disorders affecting lung development, participants in other interfering clinical trials, and families planning to move away before the child reaches 5 years of age are also excluded.
Main focus: The study aims to determine whether preventive surfactant administration works better than selective treatment using a technique called Less Invasive Surfactant Administration. Doctors will monitor how well children can breathe and how their lungs develop, with the main focus on measuring lung function at age 5.
Investigational drugs: The trial uses two surfactant medications: Alveofact (45 mg/ml phospholipid fraction from bovine lung) and Curosurf (120 mg suspension of poractant alfa). These medications contain natural substances similar to those normally found in the lungs and are given directly into the breathing tubes using Less Invasive Surfactant Administration. Surfactant helps keep the tiny air sacs in the lungs open, making it easier for premature babies to breathe.
Study on Phospholipid Fraction from Porcine Lung for Premature Infants with Respiratory Distress Syndrome (RDS)
This single-blind trial investigates two different methods of deciding when to give surfactant medication to premature babies. One method uses lung ultrasound imaging to guide treatment decisions, while the other follows current medical guidelines.
Inclusion criteria: The study enrolls premature newborns born between 24 and 32 weeks of pregnancy or weighing 1,500 grams or less at birth. Both boys and girls with respiratory distress syndrome can participate, provided they don’t meet any exclusion criteria.
Exclusion criteria: The trial excludes infants who are not born prematurely, those without respiratory distress syndrome, infants with other serious health conditions that could interfere with the study, babies who have already received treatment that could affect study results, and infants whose parents or guardians do not consent to participate.
Main focus: The primary goal is to see which method is more effective in reducing the need for intubation (placing a breathing tube) during the first 72 hours of life. Participants are randomly assigned to one of two treatment groups and monitored for their response to treatment.
Investigational drug: The trial uses Curosurf, an exogenous pulmonary surfactant containing phospholipid fraction from porcine lung. The medication is delivered directly into the lungs through a procedure called endotracheopulmonary instillation. It works by reducing surface tension in the lungs, making it easier for babies to breathe by preventing the air sacs from collapsing.
Study on the Effects of Propofol Sedation in Preterm Babies with Respiratory Distress Syndrome During LISA Procedure
This double-blind trial focuses on whether using sedation medication during the surfactant administration procedure improves outcomes for premature babies. Neither healthcare providers nor participants know who receives the sedation medication or placebo.
Inclusion criteria: The study accepts preterm infants born less than 32 weeks of gestational age who show signs of respiratory distress syndrome within the first 48 hours of life. Babies must be treated with CPAP or BiPAP breathing support and require surfactant medication. Specific oxygen level requirements must be met: 30% or more oxygen for at least 10 minutes for babies 28-31 weeks old, or 25% or more for those less than 28 weeks old. Blood oxygen saturation must be between 88% and 95%. An intravenous line must be available for medication administration. Infants must be covered by French Social Security, and parents or guardians must sign informed consent.
Exclusion criteria: The trial excludes babies born at or after 32 weeks of pregnancy, those without respiratory distress syndrome, and infants needing immediate mechanical ventilation. Babies with severe birth defects, known allergy to propofol, or those who received sedative or pain relief drugs before the procedure cannot participate. Infants with a history of very slow heart rate or very low blood pressure are also excluded.
Main focus: The study aims to determine if using propofol for sedation helps reduce the need for mechanical ventilation within the first 72 hours of life. Secondary goals include evaluating infant comfort during the procedure using the Faceless Acute Neonatal Scale and monitoring for side effects. Long-term follow-up continues until two years of age, assessing developmental milestones, motor function, and vision and hearing.
Investigational drugs: The primary medication is Propofol, an emulsion for injection or infusion given intravenously to help babies relax during the LISA procedure. If adequate comfort isn’t achieved, Ketamine (a solution for injection) may be used as rescue medication. Propofol works at the molecular level by enhancing GABA, a neurotransmitter that calms the nervous system.
Summary
Three clinical trials are currently underway to improve treatment approaches for neonatal respiratory distress syndrome in premature infants. Spain hosts two trials and participates in a third with Germany, making it the country with the most research activity in this area. France conducts one independent trial focusing on sedation during treatment procedures.
Two of the three trials investigate different aspects of surfactant medication administration, which remains the cornerstone treatment for this condition. These studies examine whether preventive versus selective administration and ultrasound-guided versus guideline-based approaches can improve outcomes. The third trial takes a different approach by studying whether sedation during surfactant administration can reduce the need for mechanical ventilation.
All trials focus on very premature infants, with gestational ages ranging from 24 to 32 weeks. The studies use established medications including Curosurf, Alveofact, and Propofol, but investigate new ways to optimize their use. Notably, one trial includes long-term follow-up until age 5, reflecting growing interest in understanding how early interventions affect child development beyond the immediate neonatal period.
