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NCT05446272 · ClinicalTrials.gov registry record · NA
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
A NA study of Bronchopulmonary Dysplasia and Death, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 478
- Enrollment target
- 20
- Study locations
NCT05446272: Recruiting NA study of Bronchopulmonary Dysplasia and Death, sponsored by University of Pennsylvania.
NCT05446272 is a NA study of Bronchopulmonary Dysplasia and Death that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 478 participants, above the 220-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (117% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05446272, a NA study of Bronchopulmonary Dysplasia and Death, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 478 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Extubation failure is defined when an infant is on the allocated mode of respiratory support and meets any of the following 4 criteria: (1) Rise in FiO2 at least 20% from pre-extubation value for \>2 hours to maintain local SpO2 targets, (2) pH ≤7.20 or pCO2 ≥70mm Hg; (3) \>1 apneic event requiring positive pressure ventilation (PPV) within 6 hours or ≥ 6 apneic events requiring stimulation within 6 hours (4) emergent intubation by the clinical team for cardiovascular instability or surgery.
Conditions Studied
Interventions
- DEVICE NIV-NAVA
- DEVICE NS-NIPPV
Study Locations (20)
California
- Loma Linda University - Loma Linda
- Sharp Mary Birch - San Diego
Florida
- Joe DiMaggio Children's Hospital - Hollywood
- AdventHealth - Orlando
Missouri
- Children's Mercy Hospital - Kansas City
- Washington University in St.Louis - St Louis
North Carolina
- Levine Children's Hospital - Charlotte
- Atrial Health Brenner Children's Hospital( Wake Forest) - Winston-Salem
Utah
- Intermountain Medical Center - Murray
- Utah Valley Hospital - Provo
Other
- Mt Sinai Hospital - Toronto
- BC Children's and Women's Hospital - Vancouver
Arkansas
- Arkansas Children's Hospital - Little Rock
Indiana
- Peyton Manning Children's Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 478 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT05446272 shows while recruiting
NCT05446272 is an interventional study that assigns participants to a tested intervention. The registered 478 participants enrollment target is mid-sized for trials with a published cap, above the 220-participant average among 29 other Bronchopulmonary Dysplasia trials with a reported enrollment target (117% higher).
The record links to 3 conditions, with Bronchopulmonary Dysplasia appearing as the primary indexed condition, and to 2 interventions - of which NIV-NAVA is the first listed.
NCT05446272 names 20 study sites across 14 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT05446272 about?
NCT05446272 is a clinical study titled "The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial". 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 intermit...
What is the current status of trial NCT05446272?
This trial is currently recruiting. It is a NA study. The enrollment target is 478 participants. The study started on 2022-08-03. Estimated completion is 2027-03-31.
What conditions does trial NCT05446272 study?
This clinical trial studies the following conditions: Bronchopulmonary Dysplasia, Death, Extubation Failure.
What interventions are being tested in trial NCT05446272?
The interventions under investigation include: NIV-NAVA (DEVICE), NS-NIPPV (DEVICE).
Who is sponsoring clinical trial NCT05446272?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05446272 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bronchopulmonary Dysplasia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05446272's enrollment target sits among peer trials
478 6th of 29 higher than 24 of 29 other Bronchopulmonary Dysplasia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bronchopulmonary Dysplasia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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