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Ventilatory Support

Ventilatory Support Methods for Extubation Failure in Preterm Infants (DIVA Trial)

N/A
Recruiting
Led By Elizabeth Foglia
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Intubated in the first 7 days of life
Undergoing extubation following at least 12 hours of invasive mechanical ventilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within the first 5 days (120 hours) post extubation
Awards & highlights

DIVA Trial Summary

This trial will compare two methods of ventilation for preterm infants to determine which is more effective in reducing the incidence of extubation failure.

Who is the study for?
The DIVA trial is for preterm infants born between 24 and 27 weeks who were intubated within their first week of life. They must be less than 28 days old when extubated after at least 12 hours on a ventilator. Infants under 500 grams, without consent, needing surgery soon, or with certain health issues can't join.Check my eligibility
What is being tested?
This study tests if NIV-NAVA (a type of breathing support that adjusts to the baby's own breathing efforts) is better than NS-NIPPV (non-synchronized nasal ventilation) in preventing failure of extubation within five days in premature infants.See study design
What are the potential side effects?
Potential side effects may include discomfort from the equipment, skin irritation around the nose or mouth from the mask or tubes used for ventilation, and possible respiratory complications due to pressure changes.

DIVA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was put on a breathing machine within my first week of life.
Select...
I have been on a breathing machine for over 12 hours and am about to be taken off.

DIVA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the first 5 days (120 hours) post extubation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the first 5 days (120 hours) post extubation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tracheal Extubation
Secondary outcome measures
Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA
Borderline Personality Disorder
Endotracheal intubation through 36 weeks PMA
+4 more
Other outcome measures
Air Leaks
Death
Gastrointestinal perforation or bleeding

DIVA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NIV-NAVAExperimental Treatment1 Intervention
Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive
Group II: NS- NIPPVActive Control1 Intervention
Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) is an FDA-approved device standardly used in clinical practice at sites to provide an effective mode of non-invasive respiratory support in preterm infants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NIV-NAVA
2016
N/A
~170

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,881,731 Total Patients Enrolled
2 Trials studying Bronchopulmonary Dysplasia
5,054 Patients Enrolled for Bronchopulmonary Dysplasia
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,837 Previous Clinical Trials
47,851,116 Total Patients Enrolled
22 Trials studying Bronchopulmonary Dysplasia
9,599 Patients Enrolled for Bronchopulmonary Dysplasia
Elizabeth FogliaPrincipal InvestigatorCHOP/UPENN

Media Library

NIV-NAVA (Ventilatory Support) Clinical Trial Eligibility Overview. Trial Name: NCT05446272 — N/A
Bronchopulmonary Dysplasia Research Study Groups: NIV-NAVA, NS- NIPPV
Bronchopulmonary Dysplasia Clinical Trial 2023: NIV-NAVA Highlights & Side Effects. Trial Name: NCT05446272 — N/A
NIV-NAVA (Ventilatory Support) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05446272 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been enrolled in this clinical exploration?

"Affirmative. Data hosted on clinicaltrials.gov validates that this medical study, which was initially posted on August 3rd 2022, is currently recruiting. A total of 478 patients are necessary to be enrolled from 12 different medical locations."

Answered by AI

How many venues have been selected to conduct this experiment?

"12 medical centres have opened their doors to patients for this clinical study, including Children's Hospital of Richmond in Richmond, Arkansas Children's Hospital in Little Rock and Loma Linda University in Loma Linda. Additionally, 9 other locations are participating."

Answered by AI

Is there currently a recruitment process for participants in this research study?

"Clinicaltrials.gov's records suggest that this clinical trial, which was initiated on August third of 2022, is still in search of participants. The listing has been recently updated as late as the 24th of August."

Answered by AI

To what demographic is this clinical trial open?

"In order to be eligible, candidates must have passed away between the ages of 0 and 28 days. The trial is seeking a total of 478 participants."

Answered by AI

Might individuals aged fifty and above be considered for participation in this investigation?

"This experiment necessitates that participants are under 28 days old and at least 0 Days in age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial
2022. "The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05446272.
~256 spots leftby Mar 2026
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