Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Utah
- Locations
- 3
- Primary Endpoint
- Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
Study Overview
Brief Summary
This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
- •Ordered respiratory treatment of NCPAP
Exclusion Criteria
- •Major congenital defect
- •Known or suspected chromosomal disorder
Arms & Interventions
Nasal CPAP
Standard Nasal CPAP
Intervention: Nasal CPAP (Device)
Oscillatory NCPAP
NCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit.
Intervention: Oscillatory NCPAP (Device)
Outcomes
Primary Outcomes
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
Time Frame: 2 months
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP.
Time Frame: 2 months
The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.
Secondary Outcomes
- Total duration of non-invasive and invasive respiratory support in each study group.(2 months)
- total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.(2 months)