Cystic FibrosisREVOLMUCONCT02358798
Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period
A study testing 3 years-assessment of respiratory function in people with Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- 3 years-assessment of respiratory function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 19 Aug 2014to 17 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient suffering from cystic fibrosis
- Height between 90 et 130cm
- No respiratory exacerbation since 4 weeks
- Benefit from an insurance disease regime
Who cannot join
- Law-protected patient
- Patient's parent don't understand french language
- Opposition to participation
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Montpellier, Arnaud de Villeneuve
Montpellier, 34295
About this study
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.
This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.
Read more
For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.
All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.
In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.
So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.
A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.
- Conditions
- Cystic Fibrosis
- Being tested
- 3 years-assessment of respiratory function
- Keywords
- Time evolution of respiratory function, Longitudinal multicenter monitoring of large cohorts, Preschool aged children, Detection of cystic fibrosis in neonatal period
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 years-assessment of respiratory functionOther
| Study group | Role | What they receive |
|---|---|---|
| Preschool aged children detected of CF in neonatal period | Experimental | Preschool aged children detected of Cystic Fibrosis in neonatal period Receives: Other: 3 years-assessment of respiratory function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
Measured: at each four yearly routine visits
Secondary outcomes (8)
airway resistance by debit interruption technique (Rint)
Measured: at each four yearly routine visits
plethysmographic measure of specific resistance (sRaw)
Measured: at each four yearly routine visits
arterial blood gas measurement
Measured: at each four yearly routine visits
pulmonary clearance index
Measured: at each four yearly routine visits
flow-volume curve
Measured: at each four yearly routine visits
measurement of organ damage
Measured: at each four yearly routine visits
measurement of tobacco exposition
Measured: at each four yearly routine visits
measure of administration antibiotics and antiasthmatics treatments
Comparison of the evolution of these parameters to changing those of a historical cohort evaluated before the introduction of neonatal screening.
Measured: at each four yearly routine visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start19 Aug 2014
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MATECKI SM Stephan, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358798
- Sponsor's protocol ID
- 9393
- Acronym
- REVOLMUCO
- Status last verified
- Apr 2020
- First submitted
- 21 Jan 2015
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Function at Preschool Age of Children Detected of Cystic Fibrosis in Neonatal Period
- ClinicalTrials.gov ID
- NCT02358798
- Acronym / sponsor ID
- REVOLMUCO / 9393
- Conditions
- Cystic Fibrosis
- Keywords
- Time evolution of respiratory function, Longitudinal multicenter monitoring of large cohorts, Preschool aged children, Detection of cystic fibrosis in neonatal period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 19 Aug 2014 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 9 Feb 2015 (estimated)
- 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.
The widespread neonatal detection of cystic fibrosis in France since 2002 permits to treat children from birth. New treatments used for young children involve to assess efficacy criteria specific to this population. Standard respiratory function criteria for older children and adults is forced expiratory volume/second.
This technique is not suited for preschool aged children (3 to 6 years old) because they are too old to be sedated and too young and immature to be able to make forced expiration technique that are correct, reproducible and prolonged during more than 1 second.
For preschool aged children, in order to assess distal damage and her consequence, the evaluations are: airway resistance by debit interruption technic (Rint), plethysmographic measure of specific resistance (sRaw), functional residual capacity by Helium dilution technique (CRF He), arterial blood gas measurement, pulmonary clearance index.
All these methods have a better success rate and can be used in alternative or with forced spirometry. However, each of them gives only a part of information on airway and lung damage of detected children. It is necessary to combine them for a better information on overall respiratory damage.
In France, each respiratory function test laboratory uses one or any of these methods in addition to flow-volume curve, in function of his practices and his equipment.
So, respiratory function test of preschool aged children is going to diversify more and more to the detriment of an homogeneity of practices between different centers.
A referent population during a longitudinal multicenter monitoring on large cohorts that describe the evolution of pulmonary function, obtained by a standardized methodology is necessary to assess the efficacy of any new treatment. And, with the homogenization of care of children detected of cystic fibrosis in different centers, the description of natural evolution of pulmonary function by a standardized methodology will improve the discriminative power of measure of respiratory function to assess the presence of a worsening in preschool-aged children.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preschool aged children detected of CF in neonatal period | Experimental | Other: 3 years-assessment of respiratory functionPreschool aged children detected of Cystic Fibrosis in neonatal period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient suffering from cystic fibrosis
- Height between 90 et 130cm
- No respiratory exacerbation since 4 weeks
- Benefit from an insurance disease regime
Key exclusion criteria (3 listed)
- Law-protected patient
- Patient's parent don't understand french language
- Opposition to participation
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 |
|---|---|---|
| 3 years-assessment of respiratory function | Other | Preschool aged children detected of CF in neonatal period |
Primary outcome
Time evolution of functional residual capacity by Helium dilution technique (CRF He)
Time frame: at each four yearly routine visits
8 secondary outcomes
airway resistance by debit interruption technique (Rint)
Time frame: at each four yearly routine visits
plethysmographic measure of specific resistance (sRaw)
Time frame: at each four yearly routine visits
arterial blood gas measurement
Time frame: at each four yearly routine visits
pulmonary clearance index
Time frame: at each four yearly routine visits
flow-volume curve
Time frame: at each four yearly routine visits
measurement of organ damage
Time frame: at each four yearly routine visits
measurement of tobacco exposition
Time frame: at each four yearly routine visits
measure of administration antibiotics and antiasthmatics treatments
Time frame: at each four yearly routine visits
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 14 Apr 2020.
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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.
MATECKI SM Stephan, MD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 years-assessment of respiratory function in people with Cystic Fibrosis, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 3 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 14 Apr 2020. 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 France. 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?
Time evolution of functional residual capacity by Helium dilution technique (CRF He) (time frame: at each four yearly routine visits). 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 14 Apr 2020.