NIV-NAVA for Death

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mt Sinai Hospital, Toronto, Canada
Death+2 More
NIV-NAVA - Device
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 24-27 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.

Eligible Conditions

  • Death
  • Extubation Failures
  • Bronchopulmonary Dysplasia

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: within the first 5 days (120 hours) post extubation

36 weeks PMA
Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
Death or BPD at 36 weeks PMA
Endotracheal intubation through 36 weeks PMA
Postmenstrual age at last invasive ventilation
Postmenstrual age at last positive pressure support
Postmenstrual age at last supplemental oxygen
Prematurity-related morbidities through 36 weeks PMA
Week 36
Air Leaks
Death
Gastrointestinal perforation or bleeding
Day 5
Extubation failure

Trial Safety

Trial Design

2 Treatment Groups

NS- NIPPV
1 of 2
NIV-NAVA
1 of 2
Active Control
Experimental Treatment

478 Total Participants · 2 Treatment Groups

Primary Treatment: NIV-NAVA · No Placebo Group · N/A

NIV-NAVAExperimental Group · 2 Interventions: NIV-NAVA or NS-NIPPV, NIV-NAVA · Intervention Types: Device, Device
NS- NIPPVActiveComparator Group · 2 Interventions: NIV-NAVA or NS-NIPPV, NS-NIPPV · Intervention Types: Device, Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIV-NAVA
2016
N/A
~170

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within the first 5 days (120 hours) post extubation
Closest Location: Mt Sinai Hospital · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2005First Recorded Clinical Trial
1 TrialsResearching Death
13 CompletedClinical Trials

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH
3,555 Previous Clinical Trials
46,914,711 Total Patients Enrolled
14 Trials studying Death
31,066,250 Patients Enrolled for Death
University of PennsylvaniaLead Sponsor
1,797 Previous Clinical Trials
36,106,084 Total Patients Enrolled
4 Trials studying Death
31,004,580 Patients Enrolled for Death
Elizabeth FogliaPrincipal InvestigatorCHOP/UPENN

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been pregnant for at least 24-27 weeks.
You are undergoing mechanical ventilation for at least 12 hours.
You are post-natal at less than 28 days of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.