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The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

NCT05446272 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2025-10-07

No results posted yet for this 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.

Conditions

  • Extubation Failure
  • Bronchopulmonary Dysplasia
  • Death

Interventions

DEVICE

NIV-NAVA

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.

DEVICE

NS-NIPPV

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.

Sponsors & Collaborators

Principal Investigators

  • Elizabeth Foglia · CHOP/UPENN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2026-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446272 on ClinicalTrials.gov