Bronchopulmonary Dysplasia Clinical Trial
— Seattle-PAPOfficial title:
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Verified date | April 2016 |
Source | Seattle Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Seattle Children's Hospital | Baylor College of Medicine, Texas Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Heart Rates | Heart rates will be assessed during the study period. | Six hours | |
Other | Transcutaneous Carbon Dioxide Levels | Transcutaneous carbon dioxide (TcPCO2) levels will be assessed. | Six hours | |
Other | Respiratory Rates | Respiratory rates will be assessed. | Six hours | |
Primary | 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 | 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 |
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