Bronchopulmonary Dysplasia Clinical Trial
Official title:
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
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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