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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04384328
Other study ID # 2018-A01898-47
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 27, 2019
Est. completion date December 31, 2022

Study information

Verified date November 2022
Source Centre Hospitalier Sud Francilien
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study, to measure the impact of an early support programme in speech and language therapy for vulnerable children (PAPEV-ortho), in children born very prematurely or very hypotrophically, on the incidence of language and communication deficits at the corrected age of 2 years.


Description:

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Study Design


Intervention

Other:
Early Support Programme in Orthophony
Early support in speech therapy lasts between 6 months and 24 months of corrected age. It includes 10 to 20 sessions depending on the child's needs. These sessions are conducted by a speech-language pathologist from the RPSOF-ASNR network, trained in the issues specific to the very premature child and the network's tools.

Locations

Country Name City State
France Ho^pital Antoine Be´cle`re Clamart
France Centre Hospitalier Louis Mourier Colombes
France Centre Hospitalier Sud Francilien Corbeil-Essonnes
France Centre Hospitalier Rives de Seine Neuilly-sur-Seine

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (16)

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Outcome

Type Measure Description Time frame Safety issue
Primary Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age. Percentage of children with a score of = 45 in the communication domain of the Ages & Stages Questionnaires questionnaire (from 0=worst to 60=best) at 24 months of corrected age at 24 months of corrected age
Secondary Failure rate of implementation of the early support program in speech-language pathology or early drop-out. Early drop-out is defined by 3 or less sessions. at 24 months of corrected age
Secondary Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age. The Ages & Stages Questionnaires is a parental questionnaire that is strongly correlated with traditional developmental tests. The Ages & Stages Questionnaires communication domain takes into account receptive and expressive language, includes 6 questions, and ranges from 0 (worst) to 60 (best). at 12 and 18 months of corrected age.
Secondary score at Inventaire Français du Développement Communicatif questionnaire at 12, 18 and 24 months of corrected age The IFDC questionnaire is a recommended tool for monitoring and early detection of language deficits. It is expressed as a percentile (0=worst, 100=best). at 12, 18 and 24 months of corrected age
Secondary Score at Communication and Symbolic Behavior Scales questionnaire at 12 and 24 months of corrected age The Communication and Symbolic Behavior Scales qestionnaire is a tool for screening for communication disorders and interactions. It ranges from 0 (worst) tro 57 (best). at 12 and 24 months of corrected age
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