NCT02210026

Seattle-PAP Bubble Nasal CPAP and Work of Breathing

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 6 Hours – 72 Hours
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Seattle-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.

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2014-08-06
• Last updated: 2016-04-14

Locations

1 site across 1 country: United States