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Completed

NCT Number: NCT02210026

Seattle-PAP Bubble Nasal CPAP and Work of Breathing

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.

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Key information

Conditions

Respiratory Distress Syndrome in Premature Infants Apnea Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Nervous System Diseases Newborn Primary Sleep Apnea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders Ventilator-Induced Lung Injury

Age range

6 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Texas Children's Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seattle-PAP

Device

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 names: Sea-PAP

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Baylor College of Medicine

Registry information

Official study title

A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

Acronym: Seattle-PAP

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 6, 2014
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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