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Completed

NCT Number: NCT02983825

Impact of CPAP Level on V/Q Mismatch in Premature Infants

Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.

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Key information

Conditions

Infant, Premature, Diseases Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Lung Diseases Lung Injury Respiratory Insufficiency Syndrome of Newborn Respiratory Tract Diseases Ventilator-Induced Lung Injury

Age range

24 hour–35 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.
  • Age limits: 24 hours of age - 35 weeks corrected gestational age.
  • On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.
  • Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) 0.25 for at least 2 consecutive hours, as documented on the bedside infant flow sheet.

Exclusion criteria

  • Congenital anomalies, as determined by the clinical supervising physician.
  • Current or prior air leak syndrome, as determined by the clinical supervising physician.

Treatment and study plan

Continuous positive airway pressure (CPAP); level changes

Device

as per arm description

Primary outcomes

  1. Ventilation/Perfusion Mismatch

    Time frame: variable; up to 2 hours

    Measured by non-invasive computerized technique based on curvilinear characteristics generated by a best-fit curve connecting the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs; measured as difference in degree of right-shift between baseline and "best" CPAP

Secondary outcomes

  1. Best CPAP Level

    Time frame: variable, up to 2 hours

    Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Thrasher Research Fund

Registry information

Official study title

Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Dec 6, 2016
Registry last updated
Mar 25, 2021

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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