Seattle-PAP Bubble Nasal CPAP and Work of Breathing

Study Overview
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Brief Summary
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The investigators propose to test the hypothesis that Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway pressure.

Detailed Description
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The primary outcome variable is work of breathing (WOB) over a two hour period, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles. The following endpoints would also be assessed: Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory rates throughout the 6 hour study period. Objective determination of when an infant requires more or less respiratory support is difficult, but measurements of pressure-rate products as estimates of work of breathing, using esophageal catheters, can estimate an infant's respiratory effort. However, objective, simple-to-use, low cost, and non-invasive methods and tools to determine an infant's respiratory effort do not exist currently. This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.

Official Title
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A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

Conditions
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Respiratory Distress Syndrome In Premature Infants, Bronchopulmonary Dysplasia, Newborn Primary Sleep Apnea

Intervention / Treatment
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* Device: Seattle-PAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infant born less than 32 weeks gestation admitted to texas pavilion for women between 6 and 72 hours post delivery stable on standard bubble nasal CPAP informed consent Exclusion Criteria: major congenital anomalies or suspected chromosomal anomalies

Ages Eligible for Study
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Minimum Age: 6 Hours
Maximum Age: 72 Hours

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP. | Device: Seattle-PAP<br>* We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.<br>* Other names: Sea-PAP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work of Breathing | The primary outcome variable is work of breathing (WOB) over three two hour periods, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles. | Six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video Recordings of Chest and Abdomen Movements during Breathing | This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters. | Six hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bubble nasal continuous positive airway pressure (Bn-CPAP), work of breathing, pressure-rate products