NCT03298035

A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).

Conditions

• Apnea of Prematurity

Interventions

Type	Name	Description
DEVICE	NCPAP as mode for apnea prevention	With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
DEVICE	NIPPV as rescue mode for apnea prevention	With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.

Timeline

• Start date: 2017-11-11
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2017-09-29
• Last updated: 2020-02-07
• Results posted: 2020-02-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study