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| Name | Class |
|---|---|
| Baylor College of Medicine | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seattle-PAP | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| FiO2 | Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period. | Six hours |
| Heart Rates | Heart rates will be assessed during the study period. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles V Smith, PhD | Seattle Children's Hospital | Study Director |
| Stephen E Welty, MD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2017 | |
| Reset | Jun 22, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2017 | Jun 22, 2017 |
| ID | Term |
|---|---|
| C566881 | Respiratory Distress Syndrome In Premature Infants |
| D001997 | Bronchopulmonary Dysplasia |
| D020182 | Sleep Apnea, Central |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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|
|
| Six hours |
| Transcutaneous Carbon Dioxide Levels | Transcutaneous carbon dioxide (TcPCO2) levels will be assessed. | Six hours |
| Respiratory Rates | Respiratory rates will be assessed. | Six hours |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |