NCT05446272 The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
| NCT ID | NCT05446272 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Extubation Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 478 participants |
| Start Date | 2022-08-03 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 478 participants in total. It began in 2022-08-03 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Elizabeth Foglia
PRINCIPAL INVESTIGATOR
CHOP/UPENN
Frequently Asked Questions
Who can join the NCT05446272 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 9 Weeks, studying Extubation Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05446272 currently recruiting?
Yes, NCT05446272 is actively recruiting participants. Contact the research team at FOGLIA@email.chop.edu for enrollment information.
Where is the NCT05446272 trial being conducted?
This trial is being conducted at Little Rock, United States, Loma Linda, United States, San Diego, United States, Hollywood, United States and 11 additional locations.
Who is sponsoring the NCT05446272 clinical trial?
NCT05446272 is sponsored by University of Pennsylvania. The principal investigator is Elizabeth Foglia at CHOP/UPENN. The trial plans to enroll 478 participants.