Back to resultsImpact of CPAP Level on V/Q Mismatch in Premature Infants
Primary Purpose
Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous positive airway pressure (CPAP); level changes
Sponsored by
About this trial
This is an interventional treatment trial for Infant, Premature, Diseases focused on measuring CPAP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
Eligibility Criteria
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.
Sites / Locations
- Hospital of the University of Pennsylvania
- The Children's Hospital of Philadelphia
- Pennsylvania Hosptital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Continuous positive airway pressure (CPAP) level changes
Arm Description
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
Outcomes
Primary Outcome Measures
Ventilation/Perfusion Mismatch
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
Best CPAP Level
Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level
Full Information
NCT ID
NCT02983825
First Posted
November 21, 2016
Last Updated
March 1, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
Thrasher Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT02983825
Brief Title
Impact of CPAP Level on V/Q Mismatch in Premature Infants
Official Title
Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 8, 2019 (Actual)
Study Completion Date
February 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Thrasher Research Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Premature, Diseases, Respiratory Insufficiency Syndrome of Newborn
Keywords
CPAP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Continuous positive airway pressure (CPAP) level changes
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure (CPAP); level changes
Intervention Description
as per arm description
Primary Outcome Measure Information:
Title
Ventilation/Perfusion Mismatch
Description
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
Time Frame
variable; up to 2 hours
Secondary Outcome Measure Information:
Title
Best CPAP Level
Description
Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level
Time Frame
variable, up to 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
35 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Bamat, MD, MSCE
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hosptital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36104165
Citation
Bamat NA, Orians CM, Abbasi S, Morley CJ, Ross Russell R, Panitch HB, Handley SC, Foglia EE, Posencheg MA, Kirpalani H. Use of ventilation/perfusion mismatch to guide individualised CPAP level selection in preterm infants: a feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):188-193. doi: 10.1136/archdischild-2022-324474. Epub 2022 Sep 14.
Results Reference
derived
Learn more about this trial
Impact of CPAP Level on V/Q Mismatch in Premature Infants
We'll reach out to this number within 24 hrs