The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-9
SponsorUniversity of Pennsylvania
About this 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 pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- NIV-NAVA
- NS-NIPPV
Treatment groups
478 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov