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

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ClinicalTrials.gov Identifier: NCT02210026
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Charles Smith, Seattle Children's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome In Premature Infants Bronchopulmonary Dysplasia Newborn Primary Sleep Apnea Device: Seattle-PAP Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Study Start Date : August 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.
 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.
Other Name: Sea-PAP


Outcome Measures
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Primary Outcome Measures :
  1. Work of Breathing [ Time Frame: Six hours ]
    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 :
  1. Video Recordings of Chest and Abdomen Movements during Breathing [ Time Frame: Six hours ]
    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.


Other Outcome Measures:
  1. FiO2 [ Time Frame: Six hours ]
    Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period.

  2. Heart Rates [ Time Frame: Six hours ]
    Heart rates will be assessed during the study period.

  3. Transcutaneous Carbon Dioxide Levels [ Time Frame: Six hours ]
    Transcutaneous carbon dioxide (TcPCO2) levels will be assessed.

  4. Respiratory Rates [ Time Frame: Six hours ]
    Respiratory rates will be assessed.


Eligibility Criteria
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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02210026


Locations
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United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Seattle Children's Hospital
Baylor College of Medicine
Investigators
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Study Director: Charles V Smith, PhD Seattle Children's
Principal Investigator: Stephen E Welty, MD Baylor College of Medicine
More Information
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Responsible Party: Charles Smith, Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT02210026    
Other Study ID Numbers: Seattle-PAP 001
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Charles Smith, Seattle Children's Hospital:
bubble nasal continuous positive airway pressure (Bn-CPAP)
work of breathing
pressure-rate products
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Sleep Apnea, Central
Premature Birth
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Lung Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury