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Trial record 10 of 363 for:    "Speech Disorder"

Language and Motor Skills of Preterm Infants in Pre-school Age: Diagnosis and Early Intervention (LAMOPRESCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426659
Recruitment Status : Completed
First Posted : August 31, 2011
Last Update Posted : June 3, 2015
European Regional Development Fund
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:

The preterm children have more difficulty minor neurological developmental than the general population even without cerebral palsy. Their oral language difficulties of language and writing have been little studied. The investigators propose to study spoken language has 3 years 1/2 and stimulate or not (depending on randomization) children with phonological weaknesses notemment language. The investigators will evaluate stimulation protocol implied short and precise language in a re-education "say and do" in 20 sessions. A new evaluation of language (BILO and N-EEL), sensorimotor and cognitive constraints (KABC) will be performed at 4 years.

Early intervention on the basis of precise language before closing the window developmental (<5 years) is expected to improve as a result of language and cognitive development of preterm infants.

Condition or disease Intervention/treatment Phase
Disorder of Speech and Language Development Behavioral: parental stimulation according to protocol Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Language and Sensorimotor Constraints of Very Premature Babies at the Age of 3 Years 1 / 2 Without Cerebral Palsy. Randomised Study of Stimulation Training Implicit in Children Vulnerable
Study Start Date : September 2011
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Protocol "say and do"
reeducation implicit 5 minutes every day at home and 30 minutes of speech therapy every week
Behavioral: parental stimulation according to protocol
verbal stimulation every day image of the Protocol "Dire et Faire"

Active Comparator: no stimulation "say and do" Behavioral: parental stimulation according to protocol
verbal stimulation every day image of the Protocol "Dire et Faire"

Primary Outcome Measures :
  1. parental endorsement of stimulation [ Time Frame: for at least 15 weeks ]
    stimulation every day image of the Protocol

Secondary Outcome Measures :
  1. come following a speech therapy every week [ Time Frame: 15 weeks ]
    constructive working session of 30 minutes according to the protocol say and do

Information from the National Library of Medicine

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Ages Eligible for Study:   34 Months to 38 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Premature < 32 without CP,
  • criteria of fragility BILO

Exclusion Criteria:

  • blindness,
  • deafness,
  • abnormal karyotype results in normal or pathological BILO

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 identifier (NCT number): NCT01426659

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University Hospital
Rouen, Haute Normandie, France, 76000
University Hospital
Caen, France, 14033
University Hospital
Grenoble, France, 38 043
University Hospital
Le Havre, France, 76600
Centre Jacques Cartier
St Brieuc, France, 22070
University Hospital
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Rouen
European Regional Development Fund
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Principal Investigator: A Charollais UH Rouen

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Responsible Party: University Hospital, Rouen Identifier: NCT01426659     History of Changes
Other Study ID Numbers: 2010/089/HP
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by University Hospital, Rouen:
early development (< 5 years)

Additional relevant MeSH terms:
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Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms