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

Not Applicable

Completed

• Conditions: Apnea of Prematurity
• Interventions: Device: NCPAP as mode for apnea prevention; Device: NIPPV as rescue mode for apnea prevention

• Registration Number: NCT03298035
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-29
• Study Start: 2017-11-11
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Results First Submitted: 2019-12-29
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-28
• Last Update Submitted: 2020-01-28
• Results First Posted: 2020-02-07
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NCPAP as mode for apnea prevention	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.
NIPPV as rescue mode for apnea prevention	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Were Intubated	28 days after randomization
Duration of Intubation	28 days after randomization

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Air Leak Disorders	36 weeks corrected gestational age	Air leak disorders include pneumothorax and/or pneumomediastinum.
Weight Gain	36 weeks corrected gestational age
Number of Apneic Events	28 days after randomization
Number of Participants With Bronchopulmonary Dysplasia (BPD)	36 weeks corrected gestational age
Length of Hospital Stay	about 10 to 18 weeks
Number of Participants Who Died	until discharge (about 10 to 18 weeks) or death
Number of Participants With Necrotizing Enterocolitis (NEC)	36 weeks corrected gestational age

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States