Back to resultsA Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Primary Purpose
Apnea of Prematurity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NCPAP as mode for apnea prevention
NIPPV as rescue mode for apnea prevention
Sponsored by
About this trial
This is an interventional treatment trial for Apnea of Prematurity
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
NCPAP as mode for apnea prevention
NIPPV as rescue mode for apnea prevention
Arm 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.
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.
Outcomes
Primary Outcome Measures
Number of Participants Who Were Intubated
Duration of Intubation
Secondary Outcome Measures
Number of Apneic Events
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Number of Participants With Necrotizing Enterocolitis (NEC)
Number of Participants With Air Leak Disorders
Air leak disorders include pneumothorax and/or pneumomediastinum.
Weight Gain
Length of Hospital Stay
Number of Participants Who Died
Full Information
NCT ID
NCT03298035
First Posted
September 26, 2017
Last Updated
January 28, 2020
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT03298035
Brief Title
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Official Title
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 11, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NCPAP as mode for apnea prevention
Arm Type
Active Comparator
Arm 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.
Arm Title
NIPPV as rescue mode for apnea prevention
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
NCPAP as mode for apnea prevention
Intervention 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.
Intervention Type
Device
Intervention Name(s)
NIPPV as rescue mode for apnea prevention
Intervention 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.
Primary Outcome Measure Information:
Title
Number of Participants Who Were Intubated
Time Frame
28 days after randomization
Title
Duration of Intubation
Time Frame
28 days after randomization
Secondary Outcome Measure Information:
Title
Number of Apneic Events
Time Frame
28 days after randomization
Title
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Time Frame
36 weeks corrected gestational age
Title
Number of Participants With Necrotizing Enterocolitis (NEC)
Time Frame
36 weeks corrected gestational age
Title
Number of Participants With Air Leak Disorders
Description
Air leak disorders include pneumothorax and/or pneumomediastinum.
Time Frame
36 weeks corrected gestational age
Title
Weight Gain
Time Frame
36 weeks corrected gestational age
Title
Length of Hospital Stay
Time Frame
about 10 to 18 weeks
Title
Number of Participants Who Died
Time Frame
until discharge (about 10 to 18 weeks) or death
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Beaullieu, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
70030
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
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