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The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
Who can join
0 Days – 9 Weeks · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- NIV-NAVA (device)
- NS-NIPPV (device)
Sponsor: University of Pennsylvania · Participants: 478 · Started: Aug 3, 2022
Contact the study team
- Elizabeth Foglia · Phone: 267-441-7144
- Lisa Wesby, MS · Phone: 215-573-6318
Official record on ClinicalTrials.gov — NCT05446272
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.