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 Health Science Center, Houston19 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Apnea of Prematurity

Interventions

NCPAP as mode for apnea preventionDEVICE

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.

NIPPV as rescue mode for apnea preventionDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Participants Who Were Intubated

Time frame: 28 days after randomization

Duration of Intubation

Time frame: 28 days after randomization

Secondary Outcomes

Number of Apneic Events

Time frame: 28 days after randomization

Number of Participants With Bronchopulmonary Dysplasia (BPD)

Time frame: 36 weeks corrected gestational age

Number of Participants With Necrotizing Enterocolitis (NEC)

Time frame: 36 weeks corrected gestational age

Number of Participants With Air Leak Disorders

Air leak disorders include pneumothorax and/or pneumomediastinum.

Time frame: 36 weeks corrected gestational age

Weight Gain

Time frame: 36 weeks corrected gestational age

Length of Hospital Stay

Time frame: about 10 to 18 weeks

Number of Participants Who Died

Time frame: until discharge (about 10 to 18 weeks) or death

Data from ClinicalTrials.gov

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