Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age (EPILANG2)
Primary Purpose
Preterm Children
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
computer-evaluation of the language
Sponsored by

About this trial
This is an interventional diagnostic trial for Preterm Children
Eligibility Criteria
Inclusion Criteria:
- Children born very preterm in 2011 in the region of Haute-Normandie in France
Exclusion Criteria:
- None
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
children born very preterm
Arm Description
A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
Outcomes
Primary Outcome Measures
Evaluation of comprehension of words and phrases level
A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.
Secondary Outcome Measures
Evaluation of production of words and phrases level
A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate production of words and phrases level will be used.
Evaluation of judgment of sentences level
A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.
Full Information
NCT ID
NCT02988570
First Posted
December 2, 2016
Last Updated
April 26, 2018
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02988570
Brief Title
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age
Acronym
EPILANG2
Official Title
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In recent years, several studies confirm that some of preterm children have language developmental disabilities, in production, in comprehension, or in written language. These language impairments lead to learning disabilities. There are, however, contradictions concerning the origin and nature of language dysfunctions. Some studies find lexical disorders (number of words used by the child), others preferentially phonological disorders (sounds used in the language), others also disorders of the morphosyntaxe (organization of the sentences) and fragilities that affect pragmatics (understanding situations).
The computer-evaluation of the language is carried out at five and a half year coupled with the medical and neuropsychological examinations. The language assessment lasts 30 to 45 minutes per child. It is carried out using a laptop computer that allows the submission of stimuli and recording of the child's responses. The language evaluation scale is the battery CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language evaluation. The assessment includes three tests: comprehension of words and phrases, production of words and phrases, and judgment of sentences. Each time, the child sees images and hears words or phrases. Sometimes he has to say what he sees on the computer screen.
As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years in the context of the follow-up of children born very preterm.
The evaluation proposed to the child in this research will be carried out at a significant period of development, before writing. This assessment will not only assess the structure of the child's language, but also determine if there are possible difficulties in learning to read and write.
The expected benefits for the health of the children included in the trial therefore concern the detection or characterization of any developmental fragilities affecting the language. These screenings or characterizations will make it possible to advocate a speech rehabilitation if necessary.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
children born very preterm
Arm Type
Experimental
Arm Description
A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
Intervention Type
Behavioral
Intervention Name(s)
computer-evaluation of the language
Intervention Description
A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
Primary Outcome Measure Information:
Title
Evaluation of comprehension of words and phrases level
Description
A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Evaluation of production of words and phrases level
Description
A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate production of words and phrases level will be used.
Time Frame
Day 1
Title
Evaluation of judgment of sentences level
Description
A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children born very preterm in 2011 in the region of Haute-Normandie in France
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane MARRET, Pr
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age
We'll reach out to this number within 24 hrs