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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.
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.
Parents of eligible children are informed of the study either during the hospitalization of the neonatal newborn by a hospital physician, or during a consultation performed during the first 6 months by a pilot physician from the RPSOF-ASNR network, hospital or private practitioner. Parents who agree that the data collected about their child may be used in the study sign a written declaration of free and informed consent.
The Early Support Programme in orthophony (PAPEV-ortho) is systematically proposed to families with possible access to a language therapist in the network.
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. The support focuses on:
Children within the group that followed the PAPEV-ortho program will be compared to children who did not benefit from this program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Support Programme in Orthophony | Experimental | 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. |
|
| Standard Care | No Intervention | Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early Support Programme in Orthophony | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michèle Granier, MD | Centre Hospitalier Sud Francilien | Study Director |
| Véronique Zupan-Simunek, MD | Hôpital Antoine Béclère | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Antoine Béclère | Clamart | 92141 | France | |||
| Centre Hospitalier Louis Mourier |
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| ID | Term |
|---|---|
| D007805 | Language Development Disorders |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
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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. |
| 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 |
| 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 |
| Colombes |
| 92700 |
| France |
| Centre Hospitalier Sud Francilien | Corbeil-Essonnes | 91100 | France |
| Centre Hospitalier Rives de Seine | Neuilly-sur-Seine | 92200 | France |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |