Comparing Two Breathing Support Methods to Help Extremely Premature Infants Breathe After Extubation

What this Trial Is About

Researchers are evaluating breathing support methods for extremely premature infants born between 23 07 and 28 67 weeks gestation who are undergoing extubation from mechanical ventilation. The study compares non-invasive neurally adjusted ventilatory assist NIV-NAVA with non-synchronized nasal intermittent positive pressure ventilation NS-NIPPV to see which method better reduces extubation failure within five days after extubation. This pragmatic, multicenter, randomized clinical trial addresses ventilator-induced lung injury, a key factor in bronchopulmonary dysplasia BPD, a leading respiratory complication in preterm infants. Participants are randomly assigned to receive either NIV-NAVA using FDA-approved devices with Edi catheters or NS-NIPPV delivered via FDA-approved ventilators commonly used at the study sites. The trial focuses on the initial five days following extubation to monitor breathing support effectiveness. Both methods are non-invasive and aim to support infants respiratory efforts with different synchronization techniques. Throughout the study, infants will be closely monitored for extubation failure within 120 hours post-extubation. Additional assessments include tracking bronchopulmonary dysplasia and related complications up to 36 weeks postmenstrual age. Researchers will collect data on ventilator use, oxygen support, and prematurity-related health issues. Participation involves regular clinical evaluations and device monitoring until study completion, with the goal of improving respiratory outcomes in this vulnerable population.

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial