NCT02988570: EPILANG2

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

Completed NA Last updated 30 April 2018

What this trial tests

NA trial testing computer-evaluation of the language in Preterm Children in 49 participants. Completed in 31 March 2017.

Timeline

10 November 2016

Primary endpoint
31 March 2017

31 March 2017

Quick facts

Lead sponsor	University Hospital, Rouen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	49
Start date	10 November 2016
Primary completion	31 March 2017
Estimated completion	31 March 2017
Sites	1 location across France

Drugs / interventions tested

• computer-evaluation of the language

Conditions studied

• Preterm Children — all drugs for Preterm Children →

Sponsor

University Hospital, Rouen

Who can join

Adults 5 to 6, any sex, with Preterm Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.