Clinical trial NCT02811029: Language and Motricity in Preterm School Age Children
Official title: Language and Motricity in Preterm School Age Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant, Premature
Keywords: neurological
difficulties
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 165
Sex: ALL
Minimum age (years): 8
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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?


Eligibility criteria: Inclusion Criteria:

* Randomization in LAMOPRESCO-1 study

Exclusion Criteria:

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

Primary outcomes:
measure: Evaluation of reading speed
timeFrame: Day 1
Secondary outcomes:
measure: Evaluation of syntax level
timeFrame: Day 1
measure: Evaluation of vocabulary level, syntax and understanding
timeFrame: Day 1
measure: Evaluation of understanding level
timeFrame: Day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Aude CHAROLLAIS, MD
role: PRINCIPAL_INVESTIGATOR
References: