Protocol for a randomised controlled trial comparing two CPAP levels to prevent extubation failure in extremely...

Area of Science:

• Neonatal Medicine
• Pediatric Respiratory Medicine
• Clinical Trials

Background:

• Respiratory distress syndrome is a major complication in extremely preterm infants, often necessitating mechanical ventilation.
• Mechanical ventilation can lead to lung injury and bronchopulmonary dysplasia, prompting early extubation attempts.
• Extubation failure, requiring reintubation, affects approximately 60% of extremely preterm infants, highlighting the need for optimized non-invasive support.

Purpose of the Study:

• To evaluate the efficacy of higher nasal continuous positive airway pressure (CPAP) pressures in reducing extubation failure in extremely preterm infants.
• To compare the rate of reintubation within 7 days when using CPAP pressures of 9-11 cm H2O versus 6-8 cm H2O.

Main Methods:

• A parallel group randomized controlled trial involving 200 extremely preterm infants prior to their first extubation.
• Infants were randomized to receive either CPAP 10 cm H2O (intervention) or CPAP 7 cm H2O (control).
• The primary outcome was extubation failure, defined as reintubation within 7 days of extubation.

Main Results:

• The study is registered (ACTRN12618001638224) and is currently in the pre-results phase.
• Statistical analysis will be conducted on an intention-to-treat basis, adjusted for gestational age and study center.

Conclusions:

• The findings will inform optimal non-invasive respiratory support strategies for extremely preterm infants post-extubation.
• This research aims to reduce the incidence of extubation failure and associated complications like bronchopulmonary dysplasia.