- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936477
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
March 16, 2023 updated by: King's College London
Functional Morphometry and Ventilation Perfusion Ratio to Estimate the Alveolar Surface Area in Prematurely Born Infants
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom
- King's College Hospital NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 months to 6 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-
Exclusion Criteria:
- Congenital or chromosomal anomalies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Assessment of alveolar surface area by functional morphometry
Non-invasive measurements of V/Q
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry
Time Frame: One year
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anne Greenough, King's College London
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2020
Primary Completion (Actual)
June 30, 2022
Study Completion (Actual)
January 30, 2023
Study Registration Dates
First Submitted
June 15, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Actual)
March 17, 2023
Last Update Submitted That Met QC Criteria
March 16, 2023
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCH20-138
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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