Bronchopulmonary Dysplasia, Newborn Primary Sleep Apnea, Respiratory Distress Syndrome In Premature Infants
Conditions
Keywords
bubble nasal continuous positive airway pressure (Bn-CPAP), work of breathing, pressure-rate products
Brief summary
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
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.
Interventions
DEVICESeattle-PAP
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.
Sponsors
Baylor College of Medicine
Seattle Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Hours to 72 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Work of Breathing | Six hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Video Recordings of Chest and Abdomen Movements during Breathing | Six hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| FiO2 | Six hours | Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period. |
| Heart Rates | Six hours | Heart rates will be assessed during the study period. |
| Transcutaneous Carbon Dioxide Levels | Six hours | Transcutaneous carbon dioxide (TcPCO2) levels will be assessed. |
| Respiratory Rates | Six hours | Respiratory rates will be assessed. |
Countries
United States
Outcome results
None listed