The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Pennsylvania
Study ID
NCT05446272
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia
  • Death
  • Extubation Failure

Eligibility Criteria

Sex
ALL
Age
0 Days - 9 Weeks
Healthy Volunteers
Not accepted

Interventions

  • NIV-NAVA — DEVICE
    Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.
  • NS-NIPPV — DEVICE
    Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.

Study Details

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.

Key Dates

Start date
Aug 3, 2022
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
478 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NIV-NAVA
  • Active Comparator: NS- NIPPV

Primary Outcome Measure

Extubation failure [ Time Frame: within the first 5 days (120 hours) post extubation ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Arkansas Children's HospitalLittle RockArkansas72202
David Matlock
[email protected]
Loma Linda UniversityLoma LindaCalifornia92350-
Sharp Mary BirchSan DiegoCalifornia92123
Anup Katheria
[email protected]
Joe DiMaggio Children's HospitalHollywoodFlorida33021
Bruce Shulman
[email protected]
AdventHealthOrlandoFlorida32803
Samarth Shukla
[email protected]
Peyton Manning Children's HospitalIndianapolisIndiana46260
Markus Tauscher
[email protected]
Norton Children's HospitalLouisvilleKentucky40202
Children's Mercy HospitalKansas CityMissouri64108
Christopher Nitkin
[email protected]
Washington University in St.LouisSt LouisMissouri63110
Roa Rakesh
[email protected]
Virtua Vorhees HospitalVoorhees TownshipNew Jersey08043
Sarvin Ghavam
[email protected]
Levine Children's HospitalCharlotteNorth Carolina28203
Eugenia Pallotto
[email protected]
Atrial Health Brenner Children's Hospital( Wake Forest)Winston-SalemNorth Carolina27157
Ricardo J Rodriguez
[email protected]
Nationwide Children's HospitalColumbusOhio43205
Matthew Kielt
[email protected]
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Elizabeth Foglia
[email protected]
Intermountain Medical CenterMurrayUtah84107
Bradley Yoder
[email protected]
Utah Valley HospitalProvoUtah84604
Bradley Yoder
[email protected]
Children's Hospital of RichmondRichmondVirginia23219
Karen Hendrick-Munoz
[email protected]

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Hospital· Little Rock, ARLoma Linda University· Loma Linda, CASharp Mary Birch· San Diego, CAJoe DiMaggio Children's Hospital· Hollywood, FLAdventHealth· Orlando, FLPeyton Manning Children's Hospital· Indianapolis, IN

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