Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants

Stopped early · Not applicable

Conditions studied: Noninvasive Ventilation, Low Birth Weight

In brief

The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive pressure ventilation (NIPPV).

Key facts

Study ID: NCT03137225
Run by: Virginia Commonwealth University
People needed: 1
Starts: 2017-04-15
Expected to finish: 2019-06-30
Last updated by the study team: 2019-11-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

< 1501 grams (VLBW (very low birth weight) infant)
Patient must be receiving daily caffeine therapy for apnea
On non-invasive ventilation, either NIPPV or non-invasive NAVA

You may not qualify if…

No concerns for acute sepsis (i.e., blood cultures, if drawn, have been negative for 48 hours, and no active signs/symptoms of sepsis).
No history of meningitis or seizures
No signs of increased intracranial pressure, including bulging fontaneIle, presence of ventricular shunt device, or ventriculomegaly by most recent ultrasound.
Presence of Grade III or IV intraventricular hemorrhage
No cyanotic heart defects or clinically significant congenital heart disease. Will allow PDA (patent ductus arteriosus), PFO (patent foramen ovale), and mild to moderate ASD (atrial septal defect)/VSD (ventricular septal defect) as determined by pediatric cardiology.
Non -English speaking legal representatives (parents)

Where it is running

Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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