EPILANG2: Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT02988570
Collaborator
(none)
49
1
1
4.6
10.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: computer-evaluation of the language
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age
Actual Study Start Date :
Nov 10, 2016
Actual Primary Completion Date :
Mar 31, 2017
Actual Study Completion Date :
Mar 31, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: children born very preterm

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
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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of comprehension of words and phrases level [Day 1]

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

Secondary Outcome Measures

  1. Evaluation of production of words and phrases level [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 [Day 1]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Children born very preterm in 2011 in the region of Haute-Normandie in France
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rouen University Hospital Rouen France

Sponsors and Collaborators

  • University Hospital, Rouen

Investigators

  • Principal Investigator: Stéphane MARRET, Pr, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT02988570
Other Study ID Numbers:
  • 2016/338/HP
First Posted:
Dec 9, 2016
Last Update Posted:
Apr 30, 2018
Last Verified:
Apr 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 30, 2018