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Seattle-PAP Bubble Nasal CPAP and Work of Breathing (Seattle-PAP)

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Seattle-PAP
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Respiratory Distress Syndrome In Premature Infants focused on measuring bubble nasal continuous positive airway pressure (Bn-CPAP), work of breathing, pressure-rate products

Eligibility Criteria

6 Hours - 72 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 4, 2014
Last Updated
April 12, 2016
Sponsor
Seattle Children's Hospital
Collaborators
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02210026
Brief Title
Seattle-PAP Bubble Nasal CPAP and Work of Breathing
Acronym
Seattle-PAP
Official Title
A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome In Premature Infants, Bronchopulmonary Dysplasia, Newborn Primary Sleep Apnea
Keywords
bubble nasal continuous positive airway pressure (Bn-CPAP), work of breathing, pressure-rate products

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.
Intervention Type
Device
Intervention Name(s)
Seattle-PAP
Other Intervention Name(s)
Sea-PAP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Work of Breathing
Description
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.
Time Frame
Six hours
Secondary Outcome Measure Information:
Title
Video Recordings of Chest and Abdomen Movements during Breathing
Description
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.
Time Frame
Six hours
Other Pre-specified Outcome Measures:
Title
FiO2
Description
Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period.
Time Frame
Six hours
Title
Heart Rates
Description
Heart rates will be assessed during the study period.
Time Frame
Six hours
Title
Transcutaneous Carbon Dioxide Levels
Description
Transcutaneous carbon dioxide (TcPCO2) levels will be assessed.
Time Frame
Six hours
Title
Respiratory Rates
Description
Respiratory rates will be assessed.
Time Frame
Six hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles V Smith, PhD
Organizational Affiliation
Seattle Children's
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Stephen E Welty, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Seattle-PAP Bubble Nasal CPAP and Work of Breathing

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