Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

Study Overview
=================
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.

Official Title
-----------------
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

Conditions
-----------------
Preterm Children

Intervention / Treatment
-----------------
* Behavioral: computer-evaluation of the language


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children born very preterm in 2011 in the region of Haute-Normandie in France Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: children born very preterm<br>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 | Behavioral: computer-evaluation of the language<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| 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. | Day 1 |