RecruitingNot Applicable

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

United States478 participantsStarted 2022-08-03

Plain-language 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.

Who can participate

Age range0 Days – 9 Weeks

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Extubation failure

Timeframe: within the first 5 days (120 hours) post extubation

Trial details

NCT IDNCT05446272

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Elizabeth Foglia

267-441-7144 FOGLIA@email.chop.edu

View on ClinicalTrials.gov More Extubation Failure trials