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

Study Overview
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Brief Summary
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Controlled randomized trial looking at Standard nasal continuous airway pressure (CPAP) respiratory support versus High Frequency CPAP in neonates who require respiratory support or who are being extubated and require support post extubation. Patients will be evaluated for need to be reintubated and oxygen requirement and PaCO2 levels

Detailed Description
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This study is a randomized controlled trial comparing High Frequency nasal CPAP versus standard nasal CPAP. The patient population includes preterm newborns who require respiratory support but do not need to be initially intubated and preterm or term infants who are being extubated and will require support for the continued lung disease. After obtaining parental consent the patient will be randomized to one of the two treatments. Patients will be followed for requirement of level of oxygen and blood gases looking at acidity (pH) and PaCO2 and Bicarbonate(HCO3). A respiratory index score will be measured. Attending physician will determine the need for the patient to be intubated or reintubated depending on the patient selected. Additionally, frequency, duration and severity of Apnea, Bradycardia and Desaturation events will be recorded. Also safety issues to include pulmonary airleak, nasal injury, facial edema and scalp edema due to straps holding the device in place will be recorded. Also gaseous distension of the stomach and intestines will be assessed and compared between treatment arms. This study is not powered to look at long term outcomes.

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

Conditions
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Neonatal Respiratory Distress Related Conditions

Intervention / Treatment
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* Device: Regular Nasal CPAP using a conventional ventilator
* Device: High Frequency Nasal CPAP


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 Nasal Continuous Airway Pressure (NCPAP) respiratory support Exclusion Criteria: Major congenital defect Known or suspected chromosomal disorder

Ages Eligible for Study
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Maximum Age: 4 Months

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: Regular Nasal CPAP using a conventional ventilator<br>Regular nasal CPAP for management of respiratory distress Patient will have regular nasal CPAP placed via nasal prongs with level of pressure adjusted and level of oxygen adjusted as needed for acceptable oxygenation and ventilation | Device: Regular Nasal CPAP using a conventional ventilator<br>* The Nasal CPAP is connected to the patient via prongs in the nose. Pressure adjustments are made to improve lung inflation. The frequency and pressure can be adjusted as needed to improve the patient's oxygen and carbon dioxide levels<br>|
| Active Comparator: High Frequency Nasal CPAP<br>High Frequency Nasal CPAP for management of respiratory distress Patient will be connected to the high frequency device through nasal prongs. The pressure, frequency and amplitude of the pulsations will be adjusted as needed to provide acceptable oxygenation and ventilation | Device: High Frequency Nasal CPAP<br>* High Frequency Nasal CPAP for management of respiratory distress Patient will be connected to the high frequency device through nasal prongs. The Bronchotron produces a pressure that is variable with an adjustable frequency that is equal or greater than 500 times per minute connecting to prongs in the patient's nose. The pressure, frequency and amplitude of the pulsations will be adjusted as needed to provide acceptable oxygenation and ventilation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Index Score (RSI) | The scale is scored based on Fio2 (0 = <30%, 1 = 30-39%, 2 = 40-49%, 3 = > or equal to 50%), CPAP/Paw (0 = <6, 1 = 6-7, 2 = 7-8, 3 = >8), Spontaneous Respiratory Rate(RR) (0 = <40, 1 = 40-59, 2 = 60-79, 3 = > or equal to 80), Retractions (0 = none, 1 = mild, 2 = moderate, 3 = severe), and Apnea (0 = none, 1 = 1/2/2015, 2 = 3/4/2015, 3 = >4). Average index scores will be compared between conditions. | 72 hours after initiation of support | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal CPAP, High Frequency NCPAP