Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants

Study Overview
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Brief Summary
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This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

Official Title
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Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)

Conditions
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Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn, Apnea of Prematurity

Intervention / Treatment
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* Other: Body positioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Viable infants born at ≤32 weeks of gestation on non-invasive NAVA. Infant must be stable on NAVA for at least 24 hours prior to the study Exclusion Criteria: Infants with congenital heart disease (CHD) Infants with persistent pulmonary hypertension (PPHN) Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 3 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 |
| --- | --- |
| Experimental: Prone positioning<br> | Other: Body positioning<br>* Body positioning of infants prone vs supine.<br>|
| Active Comparator: Supine positioning<br> | Other: Body positioning<br>* Body positioning of infants prone vs supine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak electrical activity of the diaphragm (Edi peaks) | Height of Edi signal in uV | From enrollment in study to end of study (a total of twelve hours) | 
| Minimum electrical activity of the diaphragm (Edi mins) | Lowest of Edi signal in uV | From enrollment in study to end of study (a total of twelve hours) | 
| Number of apenic events | Number of times where infant ceases to breath for >5 seconds | From enrollment in study to end of study (a total of twelve hours) | 
| Number of bradycardia events | Number of times where infant's heart rate drops <100bpm sustained for >5s | From enrollment in study to end of study (a total of twelve hours) | 
| Number of desaturation events | Number of times where infant's oxygen saturation drops <85% sustained for >5s | From enrollment in study to end of study (a total of twelve hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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apnea of prematurity, NAVA