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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02988570
Acronym
EPILANG2
Enrollment
49
Registered
2016-12-09
Start date
2016-11-10
Completion date
2017-03-31
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Children

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.

Interventions

BEHAVIORALcomputer-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

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of comprehension of words and phrases levelDay 1A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate comprehension of words and phrases will be used.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026