NCT03708406

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

October 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

October 8, 2018

Last Update Submit

March 9, 2020

Conditions

Cleft Lip and Palate

Keywords

cleft palateEustachian dysfunctionObstructive ventilation

Outcome Measures

Primary Outcomes (1)

  • Audiometry

    evaluation of the hearing threshold

    1 day

Secondary Outcomes (3)

  • nasal ventilation

    1 day

  • Eustachian tube function

    1 day

  • Facial 3D scan

    1 day

Study Arms (2)

Children with Cleft lip and palate

Children with Cleft lip and palate

Children with Cleft palate

Children with Cleft palate

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • yo children with operated clefts followed in the universitary hospital of Montpellier
  • who went to the ENT check up

You may not qualify if:

  • Thoses who skip the check up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

Middle ear effusion fluids

MeSH Terms

Conditions

Cleft LipCleft Palate

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal Abnormalities

Study Officials

  • Lylou Casteil Baume, ENT resident

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 17, 2018

Study Start

October 12, 2018

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

FR(1)