New breathing device could help tiny preemies stay off ventilators

NCT ID NCT05446272

Recruiting now Disease control Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests whether a new breathing support method called NIV-NAVA helps very preterm infants (born at 23-28 weeks) avoid breathing failure after being taken off a ventilator. About 478 infants will be randomly assigned to receive either NIV-NAVA or standard non-synchronized NIPPV. The main goal is to see if NIV-NAVA reduces the need for re-intubation within 5 days.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) device
What this could lead to: If successful, this could provide a better way to support breathing in preterm infants after they are taken off a ventilator, reducing the need for re-intubation and possibly lowering the risk of lung damage.
What could go wrong: This is a single trial, and results may not apply to all hospitals or infants. The device requires specialized training, and there is always a chance it does not improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia Death

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BRONCHOPULMONARY DYSPLASIA DEATH EXTUBATION FAILURE

Contacts and locations

Locations

AdventHealth
RECRUITING

Orlando, Florida, 32803, United States
Arkansas Children's Hospital
RECRUITING

Little Rock, Arkansas, 72202, United States
Atrial Health Brenner Children's Hospital( Wake Forest)
RECRUITING

Winston-Salem, North Carolina, 27157, United States
BC Children's and Women's Hospital
RECRUITING

Vancouver, BC V6H 3N1, Canada
Children's Hospital of Richmond
RECRUITING

Richmond, Virginia, 23219, United States
Children's Mercy Hospital
RECRUITING

Kansas City, Missouri, 64108, United States
Hospital of the University of Pennsylvania
RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Intermountain Medical Center
RECRUITING

Murray, Utah, 84107, United States
Joe DiMaggio Children's Hospital
RECRUITING

Hollywood, Florida, 33021, United States
Levine Children's Hospital
RECRUITING

Charlotte, North Carolina, 28203, United States
Loma Linda University
TERMINATED

Loma Linda, California, 92350, United States
Mt Sinai Hospital
RECRUITING

Toronto, ON M5G 1X5, Canada
Nationwide Children's Hospital
RECRUITING

Columbus, Ohio, 43205, United States
Norton Children's Hospital
RECRUITING

Louisville, Kentucky, 40202, United States
Peyton Manning Children's Hospital
RECRUITING

Indianapolis, Indiana, 46260, United States
Sharp Mary Birch
RECRUITING

San Diego, California, 92123, United States
Sunnybrook Health Sciences Centre
RECRUITING

Toronto, Ontario, M4N3M5, Canada
Utah Valley Hospital
RECRUITING

Provo, Utah, 84604, United States
Virtua Vorhees Hospital
RECRUITING

Voorhees Township, New Jersey, 08043, United States
Washington University in St.Louis
RECRUITING

St Louis, Missouri, 63110, United States

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