ADINA vs. High Flow Nasal Cannula Comparison Study

Study Overview
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Brief Summary
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This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

Detailed Description
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NCPAP has been used increasingly to manage respiratory distress in newborns as well as apnea of prematurity. Humidified high flow nasal cannula devices (flows 1-8 lpm) have also been used in neonatal intensive care units. This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

Official Title
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Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)

Conditions
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Respiratory Distress Neonatal

Intervention / Treatment
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* Device: Adaptive Dynamic Inspiratory Nasal Apparatus
* Device: High flow Nasal Canula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates admitted to NICU Weights of 400-500 grams Requiring oxygen greater than 30% No evidence of focal lobar consolidation in lung fields Exclusion Criteria: Intolerance to procedure gelatinous skin known allergy to adhesive material interference with therapy profound sepsis pneumonia unmanaged apnea/bradycardia known or suspect complex congenital heart disease severe cleft lip or palate suspect or proven lethal congenital anomaly intolerance to the interface used in the devices inability to secure an appropriate fit of the patient nasal interface considered non-viable or of uncertain viability parental refusal.

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 40 Weeks

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 |
| --- | --- |
| Experimental: High flow nasal cannula system w/ ADINA<br>The intervention is the insertion of the the ADINA device into the high flow nasal cannula system. ADINA will be placed according to weight class recommendations to increase the positive end expiratory pressure (PEEP). ADINA is actually a combination of the Neotech RAM Cannula and a clear Regulator/Pop off valve. | Device: Adaptive Dynamic Inspiratory Nasal Apparatus<br>* Oxygen will be administered via ADINA<br>* Other names: ADINA;|
| Active Comparator: high flow nasal cannula system<br>High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface. | Device: High flow Nasal Canula<br>* Oxygen will be administered via nasal canula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Oxygen Use | The length of time the patient is on oxygen will be measured in hours. | From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Concentration | ADINA will provide a concentration of oxygen between 1.5 and 4 liters which is equivalent to that provided by the conventional nasal cannula. This will be measured every twelve hours by NICU staff. | From time of randomization until time of discharge from NICU up to 100 days. | 
| Number of Participants with treatment-related pneumothorax | Participants will be monitored for pneumothorax occurrence while on ADINA and/or high flow nasal cannula. The incidence of pneumothorax occurrence in each Arm will be collected for comparison. | From time of randomization until time of discharge from NICU up to 100 days. | 
| Number of Participants with Excoriation at Nasal Site | Participants will be monitored for excoriation at the nasal site while on ADINA and/or high flow nasal cannula. The incidence of excoriation at the nasal site in each Arm will be collected for comparison. | From time of randomization until time of discharge from NICU up to 100 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Distress, Nasal CPAP, high flow nasal canula