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

NCT02988570 | Completed

• 1 other identifier: 2016/338/HP
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Evaluation of production of words and phrases level

  Day 1

• Evaluation of judgment of sentences level

  Day 1

Study Arms (1)

children born very preterm

EXPERIMENTAL

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

Behavioral: computer-evaluation of the language

Interventions

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

children born very preterm

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Study Officials

• Stéphane MARRET, Pr

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: December 9, 2016
• Study Start: November 10, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: April 30, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)