The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
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 pressu
| Condition(s) | Extubation Failure, Bronchopulmonary Dysplasia, Death |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * Gestational age of 23 0/7- 28 6/7 weeks at birth * Intubated in the first 7 days of life * Undergoing extubation following at least 12 hours of invasive mechanical ventilation * Post-natal age \<32 weeks Post menstrual age at time of extubation Exclusion Criteria: * Major congenital anomalies, including pulmonary hypoplasia * Neurologic disorders affecting respiratory drive (other than apnea of prematurity) * Esophageal bleeding or other contraindication to NG/OG catheter placement * Current weight \<500 grams (based on Edi catheter approval) * Study ventilator not available at time eligibility criteria are met * Planned surgery or invasive procedure within 5 days of extubation * Informed consent not provided |
| Ages | 0 Days to 9 Weeks |
| Sex | All |
| Lead sponsor | University of Pennsylvania |
| Locations | Little Rock, Arkansas, United States; Loma Linda, California, United States; San Diego, California, United States; Hollywood, Florida, United States; Orlando, Florida, United States; Indianapolis, Indiana, United States (+14 more sites) |
| Start date | 2022-08-03 |
| NCT ID | NCT05446272 |
| Official listing | https://clinicaltrials.gov/study/NCT05446272 |