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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
FEDER
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01426659
First received: August 29, 2011
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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 Intervention
Disorder of Speech and Language Development
Behavioral: parental stimulation according to protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • parental endorsement of stimulation [ Time Frame: for at least 15 weeks ] [ Designated as safety issue: No ]
    stimulation every day image of the Protocol


Secondary Outcome Measures:
  • come following a speech therapy every week [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
    constructive working session of 30 minutes according to the protocol say and do


Estimated Enrollment: 296
Study Start Date: September 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   34 Months to 38 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • blindness,
  • deafness,
  • abnormal karyotype results in normal or pathological BILO
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426659

Locations
France
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
FEDER
Investigators
Principal Investigator: A Charollais UH Rouen
  More Information

Publications:
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01426659     History of Changes
Other Study ID Numbers: 2010/089/HP
Study First Received: August 29, 2011
Last Updated: September 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Rouen:
language
constraints
premature
phonology
implied
early development (< 5 years)

ClinicalTrials.gov processed this record on October 19, 2014