RecruitingExtubation FailureBronchopulmonary DysplasiaDeath

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Eligible age

0–0 yrs

Accepts

All genders

Locations

12 states

Healthy volunteers

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About this 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.

Sponsor: University of Pennsylvania

You may qualify if…

✓ 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

You may not qualify if…

✕ 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