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

NCT03298035 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-02-07

Study results available
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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

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Claire Beaullieu, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-11
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03298035 on ClinicalTrials.gov