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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

Must not have

Esophageal bleeding or other contraindication to NG/OG catheter placement

Current weight <500 grams (based on Edi catheter approval)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the first 5 days (120 hours) post extubation

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was put on a breathing machine within my first week of life.

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I have been on a breathing machine for over 12 hours and am about to be taken off.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have esophageal bleeding or a condition that prevents NG/OG tube placement.

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My current weight is less than 500 grams.

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I am scheduled for surgery or a procedure within 5 days after being taken off a ventilator.

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I have a neurological disorder affecting my breathing, not including premature birth apnea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within the first 5 days (120 hours) post extubation

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tracheal Extubation

Secondary study objectives

Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA

Borderline Personality Disorder

Endotracheal intubation through 36 weeks PMA

+4 more

Other study objectives

Air Leaks

Death

Edi signal

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met