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The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Death | Bronchopulmonary Dysplasia | Extubation Failure

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    0 to 9

Participation 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

Study Location

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Maher Shahroor

[email protected]
Study Sponsored By
University of Pennsylvania
Participants Required
More Information
Study ID: NCT05446272