Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA

Completed · Not applicable

Conditions studied: Preterm Infant, BPD - Bronchopulmonary Dysplasia, Barotrauma

In brief

Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities available to extubate a preterm neonate; high flow nasal canula, nasal continuous positive airway pressure (nCPAP) and noninvasive positive pressure ventilation (NIPPV) are the most commonly used. A recent Cochrane meta-analysis concluded that NIPPV has lower extubation failure as compared to nCPAP (30% vs. 40%) NAVA (neurally adjusted ventilatory assist), a relatively new mode of mechanical ventilation in which the diaphragmatic electrical activity initiates a ventilator breath and adjustment of a preset gain (NAVA level) determines the peak inspiratory pressure. It has been reported to improve patient - ventilator synchrony and minimize mean airway pressure and ability to wean an infant from a ventilator. However till date there has been no head to head comparison of extubation failure in infants managed on NAVA with conventional ventilator strategies. In this study the investigators aim to compare primary extubation failure rates in infants/participants managed by NIPPV vs. NI-NAVA (non invasive NAVA). Eligible infants/participants will be randomized to be extubated to predefined NIPPV or NI-NAVA ventilator settings and will be assessed for primary extubation failure (defined as reintubation within 5 days after an elective extubation).

Key facts

Study ID

NCT03242057

Run by

University of Florida

People needed

30

Starts

2017-10-23

Expected to finish

2019-09-05

Last updated by the study team

2020-02-19

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams
• Postnatal age ≤ 14 days
• Inborn
• Mechanically ventilated for at least 12 hrs.
• Intubated within first 24 hrs. after birth
• Outborn infants intubated and transferred to UF within 24 hrs. after birth.

You may not qualify if…

• Outborn > 24hrs of age.
• Failed elective extubation prior to study enrollment
• Major congenital anomalies or known/suspected chromosomal anomalies
• Use of paralytics in previous 24 hrs.
• Participation in another randomized interventional trial
• Known or suspected phrenic nerve palsy or lesion
• Known or suspected diaphragmatic lesion
• Any contraindication to have a nasogastric or orogastric tube placement

Where it is running

• University of Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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