NCT04367961

Brief Summary

Observational study about children with cleft palate from surgery to pre-adolescence :Description of language development and hearing profile.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2020

Completed
Last Updated

October 6, 2020

Status Verified

April 1, 2020

Enrollment Period

5 months

First QC Date

April 26, 2020

Last Update Submit

October 5, 2020

Conditions

Deafness

Outcome Measures

Primary Outcomes (1)

  • The hearing profile is assessed though an audiogram once or twice a year during the annual follow-up with the referring surgeon. Language development is assessed by the intelligibility scale, a validated questionnaire

    The hearing profile is assessed though an audiogram once or twice a year during the annual follow-up with the referring surgeon. The hearing test will be adapted depending the age of the child. Language development is assessed by the intelligibility scale, a validated questionnaire. The parent is answering the questionnaire.

    1 day

Eligibility Criteria

Age5 Years - 11 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with a cleft vein operated on for a veloplasty at Robert Debré Hospital

You may qualify if:

  • Children aged 5 to 11 years old operated on for a veloplasty at the Robert Debré Hospital
  • operated between 2008 and 2014
  • having a cleft veil with or without a cleft lip and palate

You may not qualify if:

  • Children operated on for primary veloplasty outside the Robert Debré Hospital, and coming for secondary veloplasty.
  • Child operated on for a veloplasty for a cause other than the velar cleft.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

April 26, 2020

First Posted

April 29, 2020

Study Start

March 11, 2020

Primary Completion

July 29, 2020

Study Completion

July 29, 2020

Last Updated

October 6, 2020

Record last verified: 2020-04

Locations

FR(1)