Comparing two non-invasive ventilation methods for preterm infants after extubation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The DIVA trial is a pragmatic randomized clinical trial aimed at determining whether non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is more effective than non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) in preventing extubation failure in extremely preterm infants. The study focuses on infants born between 23 0/7 and 28 6/7 weeks gestation who are undergoing extubation after mechanical ventilation. By comparing these two ventilation strategies, the trial seeks to reduce the incidence of complications associated with extubation failure, such as bronchopulmonary dysplasia. The trial is multicenter and unblinded, involving several hospitals across the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Gestational age of 23 0/7- 28 6/7 weeks at birth
* Intubated in the first 7 days of life
* Undergoing extubation following at least 12 hours of invasive mechanical ventilation
* Post-natal age \<32 weeks Post menstrual age at time of extubation

Exclusion Criteria:

* Major congenital anomalies, including pulmonary hypoplasia
* Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
* Esophageal bleeding or other contraindication to NG/OG catheter placement
* Current weight \<500 grams (based on Edi catheter approval)
* Study ventilator not available at time eligibility criteria are met
* Planned surgery or invasive procedure within 5 days of extubation
* Informed consent not provided

Where it's running

• Arkansas Children's Hospital
  Little Rock, Arkansas, United States Recruiting
• Sharp Mary Birch
  San Diego, California, United States Recruiting
• Joe DiMaggio Children's Hospital
  Hollywood, Florida, United States Recruiting
• AdventHealth
  Orlando, Florida, United States Recruiting
• Peyton Manning Children's Hospital
  Indianapolis, Indiana, United States Recruiting
• Norton Children's Hospital
  Louisville, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Elizabeth Foglia — Chop/upenn
• Study coordinator: Elizabeth Foglia
• Email: FOGLIA@email.chop.edu
• Phone: 267-441-7144

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.