Language and Motricity in Preterm School Age Children

Infant, Premature Clinical Trial

— LAMOPRESCO2  

Official title:

Language and Motricity in Preterm School Age Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02811029
• Other study ID #: 2015/207/HP
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2016
• Last updated: August 29, 2017
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: August 2017
• Source: University Hospital, Rouen
• Contact: Aude CHAROLLAIS, MD
• Email: aude.charollais[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 8 Years

Eligibility

Inclusion Criteria:

• Randomization in LAMOPRESCO-1 study

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Infant, Premature

Intervention

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

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Evaluation of understanding level	Patient must read a text and then answer oral questions about the history read.	Day 1