Surfactant + CPAP for Neonatal Respiratory Distress Syndrome

(SPLASH Trial)

This trial explores ways to better support breathing in newborns with respiratory distress syndrome. It compares two methods: using a machine to keep airways open (Continuous Positive Airway Pressure, or CPAP) alone, or CPAP combined with a special liquid (surfactant) to help lungs expand, delivered through a simple airway device. Newborns born between 33 and 38 weeks who struggle to breathe within six hours after birth might be suitable candidates, pending a doctor's assessment of their need for breathing assistance. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance newborn care.

The trial information does not specify whether participants need to stop taking their current medications.

Previous studies have shown positive results when surfactant (a substance that helps keep the lungs open) is given to infants using a less invasive method with a special airway device. This approach has reduced the need for intubation and mechanical ventilation. However, it led to a short-term increase in oxygen needs compared to other methods. Overall, surfactant use has significantly decreased infant deaths from breathing problems, suggesting that the treatment is generally safe and effective.

For infants using CPAP (continuous positive airway pressure), research shows it is a common and non-invasive method to assist with breathing. It has been widely used and is considered safe for infants with breathing issues.

Researchers are excited about these treatments because they offer a potentially more effective way to manage Neonatal Respiratory Distress Syndrome (RDS). Unlike standard treatments that often rely solely on CPAP to provide breathing support, this trial explores the combination of CPAP with a novel surfactant delivery method called Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA). This method involves giving a single dose of surfactant (Curosurf) directly through the laryngeal or supraglottic airways, which could enhance respiratory support in newborns more efficiently. By combining non-invasive respiratory support with this innovative surfactant delivery, researchers hope to improve outcomes for infants suffering from RDS.

Research has shown that surfactant therapy has significantly reduced infant deaths and deaths from Respiratory Distress Syndrome (RDS) since its introduction. In this trial, one group of infants will receive surfactant through a supraglottic airway device (a tool placed above the vocal cords) as part of the Prophylactic Surfactant arm. Studies indicate that this method improves the success of non-invasive breathing support, with about 75% of babies needing just one dose of surfactant for effective treatment. This approach also reduces the need for more invasive breathing support, such as mechanical ventilation. Another group in this trial will receive Continuous Positive Airway Pressure (CPAP) alone, as part of the Expectant Management arm, which effectively provides ongoing breathing support without surfactant. Both treatments aim to help infants breathe more easily by keeping their airways open.¹²³⁴⁵