Surfactant Administration for Neonatal Respiratory Distress Syndrome

(SALTI Trial)

This trial explores the best way to help premature babies breathe better using a medicine called surfactant. Researchers compare two methods: one uses a thin catheter, and the other employs a special airway device placed in the baby's throat (laryngeal or supraglottic airway). The main goal is to determine which method is safer and more effective, with a focus on reducing breathing and heart rate issues. Babies born at or after 29 weeks of pregnancy, weighing more than 750 grams, and needing breathing support in the NICU may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to improving care for premature babies.

The trial information does not specify whether your baby needs to stop any current medications. It's best to discuss this with the trial team or your baby's doctor.

Research shows that both methods of administering surfactant to newborns with breathing problems are generally safe.

The laryngeal or supraglottic airway method is often less invasive and can be performed successfully. This approach is associated with fewer instances of babies requiring breathing machines and reduces the risk of early treatment failure for respiratory issues.

The thin catheter method, also known as LISA, is also safe. It often results in fewer babies needing a tube inserted into their windpipe. This method is usually well-tolerated, with fewer reported lung injuries.

Researchers are excited about these treatments for neonatal respiratory distress syndrome because they offer new ways to deliver surfactant, a substance that helps keep newborns' lungs open. Unlike the standard of care, which typically involves intubating infants to administer surfactant, these methods use a laryngeal or supraglottic airway, or a thin catheter, to deliver the medication. This could potentially minimize the need for more invasive procedures and reduce the risk of associated complications, making it a gentler option for vulnerable newborns. By exploring these less invasive methods, researchers hope to improve outcomes and make the treatment process smoother for both babies and healthcare providers.

This trial will compare two methods of surfactant administration for neonatal respiratory distress syndrome. Research has shown that both methods of administering surfactant to premature babies yield promising results. One arm of the trial uses a Laryngeal or Supraglottic Airway to deliver surfactant, effectively reducing the need for breathing machines and improving respiratory outcomes. Studies have found this approach to be successful and less invasive. The other arm administers surfactant through a thin catheter, which has also improved outcomes by reducing the need for intubation, where a tube is placed into the windpipe to assist with breathing. Both methods aim to help premature infants with breathing problems by providing surfactant, a substance that helps keep the airways open.¹²⁴⁵⁶