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Trial record 6 of 34 for:    Specific Language Impairment 1

Language and Motricity in Preterm School Age Children (LAMOPRESCO2)

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ClinicalTrials.gov Identifier: NCT02811029
Recruitment Status : Recruiting
First Posted : June 23, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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?


Condition or disease Intervention/treatment Phase
Infant, Premature Behavioral: measurement of phonology Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 165 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Language and Motricity in Preterm School Age Children
Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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




Primary Outcome Measures :
  1. Evaluation of reading speed [ Time Frame: Day 1 ]
    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.


Secondary Outcome Measures :
  1. Evaluation of syntax level [ Time Frame: Day 1 ]
    Patient must read a list of words during 2 minutes and select how much words are not correctly written.

  2. Evaluation of vocabulary level, syntax and understanding [ Time Frame: Day 1 ]
    Patient must read a list of words during 2 minutes and select how much words are not correctly written.

  3. Evaluation of understanding level [ Time Frame: Day 1 ]
    Patient must read a text and then answer oral questions about the history read.



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Ages Eligible for Study:   8 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Randomization in LAMOPRESCO-1 study

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811029


Contacts
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Contact: Aude CHAROLLAIS, MD aude.charollais@chu-rouen.fr
Contact: Julien BLOT julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France
Contact: Aude CHAROLLAIS       aude.charollais@chu-rouen.fr   
Sub-Investigator: Stéphane MARRET, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Aude CHAROLLAIS, MD Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02811029     History of Changes
Other Study ID Numbers: 2015/207/HP
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Rouen:
neurological
difficulties