Language and Motor Skills of Preterm Infants in Pre-school Age: Diagnosis and Early Intervention (LAMOPRESCO)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Rouen
Sponsor:
University Hospital, Rouen
Collaborator:
FEDER
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01426659
First received: August 29, 2011
Last updated: January 17, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | August 2014 |
| Estimated Primary Completion Date: | February 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426659
Contacts
| Contact: A Charollais | 0232885693 ext 0033 | aude.charollais@chu-rouen.fr |
| Contact: A Charollais | 0232888099 ext 0033 | aude.charollais@chu-rouen.fr |
Locations
| France | |
| University Hospital | Recruiting |
| Rouen, Haute Normandie, France, 76000 | |
| Contact: Aude Charollais, Doctor 0232888097 ext 68700 aude.charollais@chu-rouen.fr | |
| Contact: Stéphane Marret, Professor 0232888097 ext 66422 stephane.marret@chu-rouen.fr | |
| University Hospital | Recruiting |
| Caen, France, 14033 | |
| Contact: Bernard Guillois, Professor 02 31 27 25 64 guillois-b@chu-caen.fr | |
| University Hospital | Recruiting |
| Grenoble, France, 38 043 | |
| Contact: Thierry Debillon, Professor 04 76 76 55 77 Tdebillon@chu-grenoble.fr | |
| University Hospital | Recruiting |
| Le Havre, France, 76600 | |
| Contact: Benoit Delaporte, Doctor 02 32 73 36 20 benoit.delaporte@ch-havre.fr | |
| Contact: Henri Bruel, Doctor 02 32 73 36 20 henri.bruel@ch-havre.fr | |
| Centre Jacques Cartier | Recruiting |
| St Brieuc, France, 22070 | |
| Contact: Anne Busnel, Doctor 02.96.01.71.29 anne.busnel@ch-stbrieuc.fr | |
| University Hospital | Recruiting |
| Tours, France, 37000 | |
| Contact: Eli Saliba, Professor 02 47 47 47 56 saliba@med.univ-tours.fr | |
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: | January 17, 2013 |
| 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 May 16, 2013