Clinical Trials Logo

Clinical Trial Summary

DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 24-27 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.


Clinical Trial 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 240/7- 276/7 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05446272
Study type Interventional
Source University of Pennsylvania
Contact Elizabeth Foglia
Phone 267-441-7144
Email FOGLIA@email.chop.edu
Status Recruiting
Phase N/A
Start date August 3, 2022
Completion date March 31, 2027

See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A