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EPILANG2
Sponsor study identifier
interventional
49
1 country
1
Study Start
November 10, 2016
Actual (reported)Primary Completion
March 31, 2017
Actual (reported)Study Completion
March 31, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2017
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 10, 2016
Actual (reported)December 2, 2016
Actual (reported)December 9, 2016
Actual (reported)March 31, 2017
Actual (reported)March 31, 2017
Actual (reported)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
Evaluation of production of words and phrases level
Day 1
Evaluation of judgment of sentences level
Day 1
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rouen University Hospital
Rouen, France
Stéphane MARRET, Pr
University Hospital, Rouen
49 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2016
First Posted
December 9, 2016
Study Start
November 10, 2016
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 31, 2017
Actual (reported)Study Completion
March 31, 2017
Actual (reported)Last Updated
April 30, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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