Brief Title
Seattle-PAP Bubble Nasal CPAP and Work of Breathing
Official Title
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Work of Breathing
Secondary Outcome
Video Recordings of Chest and Abdomen Movements during Breathing
Condition
Respiratory Distress Syndrome In Premature Infants
Intervention
Seattle-PAP
Study Arms / Comparison Groups
Experimental
Description: Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
40
Start Date
August 2014
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility Criteria
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
Gender
All
Ages
N/A - 72 Hours
Accepts Healthy Volunteers
No
Contacts
Charles V Smith, PhD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02210026
Organization ID
Seattle-PAP 001
Responsible Party
Principal Investigator
Study Sponsor
Seattle Children's Hospital
Collaborators
Baylor College of Medicine
Study Sponsor
Charles V Smith, PhD, Study Director, Seattle Children's
Verification Date
April 2016