Language and Motricity in Preterm School Age Children (LAMOPRESCO2)

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?

Study Overview

• Status: Unknown
• Conditions: Infant, Premature
• Intervention / Treatment: Behavioral: measurement of phonology

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aude CHAROLLAIS, MD; Email: aude.charollais@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • Recruiting
    • ROUEN university hospital
    • Contact: Aude CHAROLLAIS; Email: aude.charollais@chu-rouen.fr
    • Sub-Investigator: Stéphane MARRET, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Randomization in LAMOPRESCO-1 study

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: premature infants less than 32 weeks of age; measurement of phonology in premature infants less than 32 weeks of age who participated to LAMOPRESCO-1 study	Behavioral: measurement of phonology; measurement of phonology will be assess using BILO-3, EDA, VS and VL tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of syntax level	Patient must read a list of words during 2 minutes and select how much words are not correctly written.	Day 1
Evaluation of vocabulary level, syntax and understanding	Patient must read a list of words during 2 minutes and select how much words are not correctly written.	Day 1
Evaluation of understanding level	Patient must read a text and then answer oral questions about the history read.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Aude CHAROLLAIS, MD, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: neurological; difficulties
• Other Study ID Numbers: 2015/207/HP

Plan for Individual participant data (IPD)

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