N/A N=19 Randomized Treatment

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

Apnea of Prematurity

Bottom Line

View on ClinicalTrials.gov: NCT03298035 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants Who Were Intubated — 6; 8 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: NCPAP as mode for apnea prevention (Device); NIPPV as rescue mode for apnea prevention (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Were Intubated	6; 8	—
PRIMARY Duration of Intubation	10.6; 17.5	—
SECONDARY Number of Apneic Events	3.78; 6.22	—
SECONDARY Number of Participants With Bronchopulmonary Dysplasia (BPD)	9; 8	—
SECONDARY Number of Participants With Necrotizing Enterocolitis (NEC)	1; 5	—
SECONDARY Number of Participants With Air Leak Disorders	0; 0	—
SECONDARY Weight Gain	—	—
SECONDARY Length of Hospital Stay	136; 149	—
SECONDARY Number of Participants Who Died	1; 0	—

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).

Eligibility Criteria

Inclusion Criteria

Infants born at 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03298035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.