Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

Study Overview
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Brief Summary
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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.

Official Title
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Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

Conditions
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Respiratory Distress Syndrome, Prematurity

Intervention / Treatment
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* Device: Nasal CPAP
* Device: Oscillatory NCPAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

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: Nasal CPAP<br>Standard Nasal CPAP | Device: Nasal CPAP<br>* NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.<br>|
| Active Comparator: Oscillatory NCPAP<br>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. | Device: Oscillatory NCPAP<br>* Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.<br>* Other names: Bird Industries;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP | Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP | 2 months | 
| Need for mechanical ventilation following the initiation of NCPAP. | The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of non-invasive and invasive respiratory support in each study group. | Determine the 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. | Determine the total amount of oxygen exposure in each study group. | 2 months |