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

Not Applicable

Completed

• Conditions: Preterm Children
• Interventions: Behavioral: computer-evaluation of the language

• Registration Number: NCT02988570
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-10
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-09
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
children born very preterm	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

Primary Outcome Measures

Name	Time	Method
Evaluation of comprehension of words and phrases level	Day 1	A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.

Secondary Outcome Measures

Name	Time	Method
Evaluation of production of words and phrases level	Day 1	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	Day 1	A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France