The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
University of Pennsylvania
478 participants
Aug 3, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria7
- 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
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Interventions
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.
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.
Locations(20)
View Full Details on ClinicalTrials.gov
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NCT05446272