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Completed

NCT Number: NCT02988570

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

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.

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Key information

Conditions

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

computer-evaluation of the language

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

Primary outcomes

  1. Evaluation of comprehension of words and phrases level

    Time frame: Day 1

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

Secondary outcomes

  1. Evaluation of production of words and phrases level

    Time frame: Day 1

    A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate production of words and phrases level will be used.

  2. Evaluation of judgment of sentences level

    Time frame: Day 1

    A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: EPILANG2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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