Seattle-PAP Bubble Nasal CPAP and Work of Breathing

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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