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

The University of Texas System (UT)

Status: Completed

Conditions: Apnea of Prematurity

Treatments: Device: NCPAP as mode for apnea prevention; Device: NIPPV as rescue mode for apnea prevention

Study type: Interventional

Funder types: Other

Identifiers

NCT03298035

HSC-MS-17-0458

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
• Infants on maximum caffeine therapy (10mg/kg/day)

Exclusion criteria

• Major congenital anomalies including congenital heart disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

19 participants in 2 patient groups

NCPAP as mode for apnea prevention

Active Comparator group

Description:

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.

Treatment:

Device: NCPAP as mode for apnea prevention

NIPPV as rescue mode for apnea prevention

Experimental group

Description:

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.

Treatment:

Device: NIPPV as rescue mode for apnea prevention