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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Children
• Intervention / Treatment: Behavioral: computer-evaluation of the language

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France
    • Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 6 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of production of words and phrases level	A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate production of words and phrases level will be used.	Day 1
Evaluation of judgment of sentences level	A computer-based language evaluation battery (Cléa) comprising standardized test to evaluate judgment of sentences level will be used.	Day 1

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2016
• Primary Completion (ACTUAL): March 31, 2017
• Study Completion (ACTUAL): March 31, 2017

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (ESTIMATE): December 9, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2016/338/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO