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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02983825
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : July 30, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infant, Premature, Diseases Respiratory Insufficiency Syndrome of Newborn Device: Continuous positive airway pressure (CPAP); level changes Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : July 8, 2019
Actual Study Completion Date : February 13, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Continuous positive airway pressure (CPAP) level changes
Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline
 Device: Continuous positive airway pressure (CPAP); level changes
as per arm description


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   24 Hours to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.
  2. Age limits: 24 hours of age - 35 weeks corrected gestational age.
  3. On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.
  4. 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:

  1. Congenital anomalies, as determined by the clinical supervising physician.
  2. Current or prior air leak syndrome, as determined by the clinical supervising physician.
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): NCT02983825


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hosptital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Children's Hospital of Philadelphia
Thrasher Research Fund
Investigators
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Principal Investigator: Nicolas Bamat, MD, MSCE University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:
Study Protocol and Statistical Analysis Plan  [PDF] February 20, 2019

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02983825    
Other Study ID Numbers: 17-013910
825874 ( Other Identifier: University of Pennsylvania )
First Posted: December 6, 2016    Key Record Dates
Results First Posted: July 30, 2020
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Children's Hospital of Philadelphia:
CPAP
Bronchopulmonary Dysplasia
Ventilator Induced Lung Injury
V/Q mismatch
Additional relevant MeSH terms:
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Respiratory Insufficiency
Premature Birth
Infant, Premature, Diseases
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Respiration Disorders
Respiratory Tract Diseases
Infant, Newborn, Diseases