Cleft Lip and PalateClef PalateNCT03708406
Otologic and Rhinologic Outcomes in Children With Clef Palate
An observational study of Cleft Lip and Palate, run by University Hospital, Montpellier at 1 site in France.
Trial summary
OBJECTIVE: To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft. DESIGN: Monocentric retrospective and prospective analysis of medical reports. Read more about this study
- Who is it for?
- Ages 9 to 11 years
- Conditions the study is for
- Cleft Lip and Palate
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2018to 30 Dec 2019
- Phase
- Observational
- 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 9 to 11 years
- All sexes
- No healthy volunteers
- Child
Study population: All consecutively treated patients affected by a cleft lip and palate or a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.
Who may be able to join
- 10 yo children with operated clefts followed in the universitary hospital of Montpellier
- who went to the ENT check up
Who cannot join
- Thoses who skip the check up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years
OBJECTIVE:
To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.
DESIGN:
Monocentric retrospective and prospective analysis of medical reports.
PATIENTS, PARTICIPANTS:
All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.
INTERVENTIONS:
Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.
MAIN OUTCOME MEASURE(S):
The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.
- Conditions
- Cleft Lip and Palate
- Keywords
- cleft palate, Eustachian dysfunction, Obstructive ventilation
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with Cleft lip and palate | Children with Cleft lip and palate | |
| Children with Cleft palate | Children with Cleft palate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Audiometry
evaluation of the hearing threshold
Measured: 1 day
Secondary outcomes (3)
nasal ventilation
Nasal ventilation will be assessed with passive anterior rhinomanometry
Measured: 1 day
Eustachian tube function
Eustachian tube function will be assessed with tubomanometry
Measured: 1 day
Facial 3D scan
Facial 3D scan will be used to measure 2 criteria :
- Total volum of the mastoid
- Total volum of the mastoid's cells (pneumatization)
Facial 3D scan will be used to measure 2 criteria :
- Total volum of the mastoid
- Total volum of the mastoid's cells (pneumatization)
Facial 3D scan will be used to measure 2 criteria :
- Total volum of the mastoid
- Total volum of the mastoid's cells (pneumatization)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start12 Oct 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lylou Casteil Baume, ENT resident, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708406
- Sponsor's protocol ID
- RECHMPL18_0374
- Acronym
- Clef Palate
- Status last verified
- Mar 2020
- First submitted
- 8 Oct 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Otologic and Rhinologic Outcomes in Children With Cleft Palate at Age 10 Years
- ClinicalTrials.gov ID
- NCT03708406
- Acronym / sponsor ID
- Clef Palate / RECHMPL18_0374
- Conditions
- Cleft Lip and Palate
- Keywords
- cleft palate, Eustachian dysfunction, Obstructive ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 17 Oct 2018 (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.
OBJECTIVE:
To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.
DESIGN:
Monocentric retrospective and prospective analysis of medical reports.
PATIENTS, PARTICIPANTS:
All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.
INTERVENTIONS:
Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.
MAIN OUTCOME MEASURE(S):
The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with Cleft lip and palate | – | –Children with Cleft lip and palate |
| Children with Cleft palate | – | –Children with Cleft palate |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All consecutively treated patients affected by a cleft lip and palate or a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.
Key inclusion criteria (2 listed)
- 10 yo children with operated clefts followed in the universitary hospital of Montpellier
- who went to the ENT check up
Key exclusion criteria (1 listed)
- Thoses who skip the check up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Audiometry
Time frame: 1 day
evaluation of the hearing threshold
3 secondary outcomes
nasal ventilation
Time frame: 1 day
Eustachian tube function
Time frame: 1 day
Facial 3D scan
Time frame: 1 day
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 10 Mar 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.
Lylou Casteil Baume, ENT resident 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?
An observational study of Cleft Lip and Palate, 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 2 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 10 Mar 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?
Audiometry (time frame: 1 day). 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 Mar 2020.