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

NCT ID: NCT02988570

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-10

Study Completion Date

2017-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Children

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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children born very preterm

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

Group Type EXPERIMENTAL

computer-evaluation of the language

Intervention Type BEHAVIORAL

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

Interventions

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computer-evaluation of the language

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

Eligibility Criteria

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Inclusion Criteria

* Children born very preterm in 2011 in the region of Haute-Normandie in France

Exclusion Criteria

* None
Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphane MARRET, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2016/338/HP

Identifier Type: -

Identifier Source: org_study_id