NCT05446272

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 478 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 0 Days – 9 Weeks
• Healthy volunteers: Not accepted

Summary

DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.

Detailed description

Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. Ventilator induced lung injury (VILI) an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Because even brief exposure to intubated positive pressure ventilation is injurious, avoiding invasive mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of therapy. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial is an unblinded, pragmatic, multicenter phase III randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation

Conditions

• Extubation Failure
• Bronchopulmonary Dysplasia
• Death

Interventions

Type	Name	Description
DEVICE	NIV-NAVA	Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.
DEVICE	NS-NIPPV	Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.

Timeline

• Start date: 2022-08-03
• Primary completion: 2026-03-31
• Completion: 2027-03-31
• First posted: 2022-07-06
• Last updated: 2025-10-07

Locations

20 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study