Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Study Overview
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Brief Summary
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Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.

Detailed Description
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Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events (breaths) are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).

Official Title
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Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Conditions
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Respiratory Distress Syndrome in Premature Infant

Intervention / Treatment
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* Device: Nasal interface


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronologic age less than 28 days Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days Currently receiving NIPPV, NIV NAVA, or nCPAP Exclusion Criteria: Oxygen requirement greater than 40% Peak inspiratory pressure greater than 20 cm H2O Major congenital anomalies of the heart or lungs

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: nCPAP prongs<br> | Device: Nasal interface<br>* Randomized to initial interface of nCPAP prongs or infant cannula<br>* Other names: Miniflow Nasal CPAP Prongs;|
| Active Comparator: Infant cannula<br> | Device: Nasal interface<br>* Randomized to initial interface of nCPAP prongs or infant cannula<br>* Other names: Miniflow Nasal CPAP Prongs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative tidal volume delivery, breath type I | Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths | 1 hour | 
| Relative tidal volume delivery, breath type II | Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths | 1 hour | 
| Relative tidal volume delivery, breath type III | Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator pressure delivery |  | 1 hour | 
| Ventilator flow delivery |  | 1 hour | 
| Heart rate |  | 1 hour | 
| Oxygen saturation |  | 1 hour | 
| Transcutaneous carbon dioxide tension |  | 1 hour | 
| Transcutaneous oxygen tension |  | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal intermittent positive pressure ventilation, non-invasive ventilation, nasal continuous positive airway pressure prongs, infant nasal cannula, tidal volume