Language and Motricity in Preterm School Age Children

NCT02811029 | Terminated

• 1 other identifier: 2015/207/HP
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure. Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders, executive function disorders as well as attention and behaviour disorders. Developmental language disorders have been rarely reported in the literature. This originally prompted our request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol has studied the language development of children who were born very prematurely, aged 3 and a half years free of cerebral palsy, in particular the impact of a short rehabilitation period, precise, at an early stage, and protocolized on a fundamental sensorimotor language. The principal assessment criterion was the measurement of phonology, the cornerstone of oral and written language in humans. The aim of the present project is an analysis of the effect that this specific language stimulation has on the learning of written language. The hypothesis is that a specific work modifying various aspects of a child's language, during the age of 3 to 4, alters the development of phonological skills in a sustainable way. The acquisition of reading skills is basically dependent on the quality of its phonological components. The randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing difficulties have been reported as regards the language understanding of 3 to 15 year old children. It is as if the initial difficulties and weaknesses, which moreover constituted oral language, prevented the use or development of neural networks, which became more complex and required both an oral and written language. Are these elements which constitute phonology, at an early stage, modifiable before the close of the clinically measurable developmental window?

Conditions

Infant, Premature

Keywords

neurological; difficulties

Outcome Measures

Primary Outcomes (1)

• Evaluation of reading speed

  Evaluation of reading speed will be assess using silent reading speed test. Patient must read a list of words during 2 minutes. The total number of read words will be analyse to calculate the reading speed.

  Day 1

Secondary Outcomes (3)

• Evaluation of syntax level

  Day 1

• Evaluation of vocabulary level, syntax and understanding

  Day 1

• Evaluation of understanding level

  Day 1

Study Arms (1)

premature infants less than 32 weeks of age

EXPERIMENTAL

measurement of phonology in premature infants less than 32 weeks of age who participated to LAMOPRESCO-1 study

Behavioral: measurement of phonology

Interventions

measurement of phonology BEHAVIORAL

measurement of phonology will be assess using BILO-3, EDA, VS and VL tests

premature infants less than 32 weeks of age

Eligibility Criteria

• Age: 8 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Randomization in LAMOPRESCO-1 study

You may not qualify if:

• None as the same population as in the LAMOPRESCO study will be included

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Premature Birth; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aude CHAROLLAIS, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 23, 2016
• Study Start: June 29, 2016
• Primary Completion: December 11, 2018
• Study Completion: December 11, 2018
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)