Bronchopulmonary DysplasiaNCT04936477
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
A study testing Calculation of ventilation-perfusion ratio in people with Bronchopulmonary Dysplasia, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 28 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Calculation of ventilation-perfusion ratio
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Sep 2020to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -
Who cannot join
- Congenital or chromosomal anomalies
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London
About this study
Official title: 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Calculation of ventilation-perfusion ratio
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculation of ventilation-perfusion ratioOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Assessment of alveolar surface area by functional morphometry | Experimental | Non-invasive measurements of V/Q Receives: Other: Calculation of ventilation-perfusion ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start29 Sep 2020
- Primary completion30 Jun 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Anne Greenough, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936477
- Sponsor's protocol ID
- KCH20-138
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Morphometry and Ventilation Perfusion Ratio to Estimate the Alveolar Surface Area in Prematurely Born Infants
- ClinicalTrials.gov ID
- NCT04936477
- Acronym / sponsor ID
- KCH20-138
- Conditions
- Bronchopulmonary Dysplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assessment of alveolar surface area by functional morphometry | Experimental | Other: Calculation of ventilation-perfusion ratioNon-invasive measurements of V/Q |
Who may qualify
- Ages
- 22 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Congenital or chromosomal anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calculation of ventilation-perfusion ratioThree 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. | Other | Assessment of alveolar surface area by functional morphometry |
Primary outcome
Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Greenough principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calculation of ventilation-perfusion ratio in people with Bronchopulmonary Dysplasia, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the alveolar surface area in prematurely born infants using validated functional morphometry (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.