NCT03298035
Completed
Not Applicable
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, Houston1 site in 1 country19 target enrollmentNovember 11, 2017
ConditionsApnea of Prematurity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Apnea of Prematurity
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Were Intubated
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Catherine Claire Beaullieu
Neonatal-Perinatal Medicine Fellow
The University of Texas Health Science Center, Houston
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
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(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)
- Number of Participants With Air Leak Disorders(36 weeks corrected gestational age)
- Weight Gain(36 weeks corrected gestational age)
Study Sites (1)
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