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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
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Preterm Children

Eligibility Criteria

5 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
December 2, 2016
Last Updated
April 26, 2018
Sponsor
University Hospital, Rouen
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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

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