Evaluation of an Early Support Programme in Orthophony

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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: the development of parental sensitivity and receptivity the development of parental reactivity optimization of communication sequences in routine acts and play the development of the child's intentionality in play and routine acts support for verbal and non-verbal oral communication The participation of the child and his or her parents in the study ends at the end of the consultations and evaluations carried out at 24 months of corrected age. Children within the group that followed the PAPEV-ortho program will be compared to children who did not benefit from this program.

Official Title
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Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study

Conditions
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Language Development Disorders, Preterm Birth

Intervention / Treatment
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* Other: Early Support Programme in Orthophony


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premature birth < 32 weeks of amenorrhea or premature birth with intrauterine growth restriction (IUGR) < P3 corrected age ≤ 6 months at the time of inclusion affiliation to a social security system + mutual insurance Exclusion Criteria: genetic pathology ongoing developmental care: psychomotricity or speech therapy neuromuscular pathology affecting oral and facial motor skills severe oral disorders: feeding by gastric tube or gastrostomy severe sensory, auditory or visual impairment neither of the 2 French-speaking parents

Ages Eligible for Study
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Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Support Programme in Orthophony<br>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. | Other: Early Support Programme in Orthophony<br>* 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.<br>|
| No Intervention: Standard Care<br>Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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language Development, communication Development, preterm infant, orthophony