Back to resultsVentilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
Primary Purpose
Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Calculation of ventilation-perfusion ratio
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchopulmonary Dysplasia
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
- Congenital or chromosomal anomalies
Sites / Locations
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Assessment of alveolar surface area by functional morphometry
Arm Description
Non-invasive measurements of V/Q
Outcomes
Primary Outcome Measures
Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry
Secondary Outcome Measures
Full Information
NCT ID
NCT04936477
First Posted
June 15, 2021
Last Updated
March 16, 2023
Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT04936477
Brief Title
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
Official Title
Functional Morphometry and Ventilation Perfusion Ratio to Estimate the Alveolar Surface Area in Prematurely Born Infants
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
January 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
King's College Hospital NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To non-invasively estimate the alveolar surface area of the lungs of prematurely born infants by taking measurements of oxygen and carbon dioxide and utilizing functional morphometry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Assessment of alveolar surface area by functional morphometry
Arm Type
Experimental
Arm Description
Non-invasive measurements of V/Q
Intervention Type
Other
Intervention Name(s)
Calculation of ventilation-perfusion ratio
Intervention Description
Three to five paired measurements of fraction of inspired oxygen and peripheral oxygen saturations.
Insertion of mainstream capnograph with combined pressure and flow sensor to perform end-tidal capnography measurement.
Echocardiogram to assess intra-cardiac shunting.
Primary Outcome Measure Information:
Title
Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
Congenital or chromosomal anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Greenough
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
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