Purpose

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).

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Device: 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.
Experimental
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.
  • Device: 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.

More Details

Status
Completed
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.