Nose Deformities, AcquiredMODERNNCT02815345
Objectives and Measures Dimensions Nasal Resistance of Preterm and Term (MODERN)
A study testing Rhinometry in people with Nose Deformities, Acquired, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA), definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was 32% . Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Nose Deformities, Acquired
- What is being tested?
- Rhinometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Dec 2018
- 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Affiliation to social security
- Informed Parental Consent
- Newborns term and preterm
- Age less than or equal to 28 days
- Signature of informed consent by both parents
Who cannot join
- craniofacial malformation
- Dyspnea (Silverman score> 3)
- severe sepsis
- life-threatened
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn
During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA), definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was 32% . In the same study, the median number of attempts before achieving a final withdrawal was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and little studied. It seems that the type of interface used, mask or cannula, having an influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by non-invasive ventilation are not uncommon, regardless of the interface used . In a recent randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and non-invasive ventilation mode. It is in this case external damage. But we assume that the breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors are likely to generate a nasal obstruction, source intervention nurses who aspire nasal passages more or less traumatic.
The nasal cavities are often abused and, because of their key role in breathing, could be involved in the withdrawal of ventilatory failure
Read the detailed description
The measurements of the nasal cavity dimensions are carried out by acoustic rhinometry (about 10 seconds for an acquisition). Measurement of nasal resistance is performed by rhinomanometry earlier (about a minute to a measure). They may be made to wakefulness or sleep since they do not require their participation. These measures will be carried at birth and then every 7 to 10 days (before the age of 28 days), if the child is still hospitalized.
During these measurements, the heart rate and oxygen saturation are collected by a measuring sensor transcutaneously.
- Conditions
- Nose Deformities, Acquired
- Being tested
- Rhinometry
- Medical subject headings
- Nose Deformities, Acquired
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinometryDevice
An acoustic rhinometry device will be used to evaluate the area and the volume of the nasal cavities. Both nasal cavities will be measured except for patients with nasogastric tube.
| Study group | Role | What they receive |
|---|---|---|
| Measure of the nasal cavity | Experimental | The nasal cavity of all the included neonates will be measured using rhinometry during their hospitalization every weeks. So one to 8 measurement will be performed for each neonates.
Some included neonates will also have rhinomanometry measurements. Receives: Device: Rhinometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal cross sectional area measured by acoustic rhinometry
Acoustic rhinometry is a functional non-invasive procedure based on the sound reflection of acoustic waves on the nasal cavities. This procedure allows determining the geometry and the size of nasal cavities. The device is composed by a wave tube connected to a sound generator emitting series of acoustic impulsions. On this wave tube are laterally connected 2 microphones, themselves connected with a computer which analyzes the acoustic signal. These microphones detect the acoustic reflected wave.
Measured: during the hospitalization of the infants, from birth to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose Deformities, AcquiredStudies of the same condition, open and under way.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude Danan, Centre Hospitalier Intercommunal Creteil
- Investigators
- Claude CD DANAN, MD, Principal investigator, CHI Créteil Neonatalogy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815345
- Sponsor's protocol ID
- CHIC MODERN
- Acronym
- MODERN
- Status last verified
- Feb 2023
- First submitted
- 3 May 2016
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination by a Noninvasive Method of the Geometric Dimensions of the Nasal Cavities of the Premature Newborn
- ClinicalTrials.gov ID
- NCT02815345
- Acronym / sponsor ID
- MODERN / CHIC MODERN
- Conditions
- Nose Deformities, Acquired
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 28 Jun 2016 (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.
During the resuscitation of preterm infants, withdrawal of non-invasive ventilation is difficult. In a recent study in children gestational age <30 weeks of amenorrhea (SA), definitive withdrawal rate from the first attempt to stop the non-invasive ventilation was 32% . In the same study, the median number of attempts before achieving a final withdrawal was 3 for children born before 28 weeks. The reasons for weaning failure are multiple and little studied. It seems that the type of interface used, mask or cannula, having an influence on the effectiveness of non-invasive ventilation . The nasal lesions induced by non-invasive ventilation are not uncommon, regardless of the interface used . In a recent randomized trial, they ranged from 40% to 50% depending on the type of nasal cannula and non-invasive ventilation mode. It is in this case external damage. But we assume that the breakdown causes internal lesions dependent on the pressure, humidity and flow. These factors are likely to generate a nasal obstruction, source intervention nurses who aspire nasal passages more or less traumatic.
The nasal cavities are often abused and, because of their key role in breathing, could be involved in the withdrawal of ventilatory failure
Detailed description
The measurements of the nasal cavity dimensions are carried out by acoustic rhinometry (about 10 seconds for an acquisition). Measurement of nasal resistance is performed by rhinomanometry earlier (about a minute to a measure). They may be made to wakefulness or sleep since they do not require their participation. These measures will be carried at birth and then every 7 to 10 days (before the age of 28 days), if the child is still hospitalized.
During these measurements, the heart rate and oxygen saturation are collected by a measuring sensor transcutaneously.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Measure of the nasal cavity | Experimental | Device: RhinometryThe nasal cavity of all the included neonates will be measured using rhinometry during their hospitalization every weeks. So one to 8 measurement will be performed for each neonates. Some included neonates will also have rhinomanometry measurements. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Affiliation to social security
Key exclusion criteria (4 listed)
- craniofacial malformation
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 |
|---|---|---|
| RhinometryAn acoustic rhinometry device will be used to evaluate the area and the volume of the nasal cavities. Both nasal cavities will be measured except for patients with nasogastric tube. | Device | Measure of the nasal cavity |
Primary outcome
Minimal cross sectional area measured by acoustic rhinometry
Time frame: during the hospitalization of the infants, from birth to week 8
Acoustic rhinometry is a functional non-invasive procedure based on the sound reflection of acoustic waves on the nasal cavities. This procedure allows determining the geometry and the size of nasal cavities. The device is composed by a wave tube connected to a sound generator emitting series of acoustic impulsions. On this wave tube are laterally connected 2 microphones, themselves connected with a computer which analyzes the acoustic signal. These microphones detect the acoustic reflected wave.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Individual participant dataSharing planned: No
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.
Claude CD DANAN, MD principal investigator
CHI Créteil Neonatalogy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhinometry in people with Nose Deformities, Acquired, run by Centre Hospitalier Intercommunal Creteil 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 10 Feb 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 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 was stopped early. Results are not available in the source record.
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?
Minimal cross sectional area measured by acoustic rhinometry (time frame: during the hospitalization of the infants, from birth to week 8). 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 10 Feb 2023.