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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Apnea of Prematurity

Intervention / Treatment
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* Device: NCPAP as mode for apnea prevention
* Device: NIPPV as rescue mode for apnea prevention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NCPAP as mode for apnea prevention<br>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: NCPAP as mode for apnea prevention<br>* 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.<br>|
| Experimental: NIPPV as rescue mode for apnea prevention<br>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. | Device: NIPPV as rescue mode for apnea prevention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were Intubated |  | 28 days after randomization | 
| Duration of Intubation |  | 28 days after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Apneic Events |  | 28 days after randomization | 
| Number of Participants With Bronchopulmonary Dysplasia (BPD) |  | 36 weeks corrected gestational age | 
| Number of Participants With Necrotizing Enterocolitis (NEC) |  | 36 weeks corrected gestational age | 
| Number of Participants With Air Leak Disorders | Air leak disorders include pneumothorax and/or pneumomediastinum. | 36 weeks corrected gestational age | 
| Weight Gain |  | 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 |