Clinical trial NCT04384328: Evaluation of an Early Support Programme in Orthophony
Official title: Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Language Development Disorders
Preterm Birth
Keywords: language Development
communication Development
preterm infant
orthophony
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 76
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.
timeFrame: at 24 months of corrected age
Secondary outcomes:
measure: Failure rate of implementation of the early support program in speech-language pathology or early drop-out.
timeFrame: at 24 months of corrected age
measure: Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.
timeFrame: at 12 and 18 months of corrected age.
measure: score at Inventaire Français du Développement Communicatif questionnaire at 12, 18 and 24 months of corrected age
timeFrame: at 12, 18 and 24 months of corrected age
measure: Score at Communication and Symbolic Behavior Scales questionnaire at 12 and 24 months of corrected age
timeFrame: at 12 and 24 months of corrected age
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Colombes
country: France
facility: Centre Hospitalier Louis Mourier
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Neuilly-sur-Seine
country: France
facility: Centre Hospitalier Rives de Seine
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Michèle Granier, MD
role: STUDY_DIRECTOR
affiliation: Hôpital Antoine Béclère
name: Véronique Zupan-Simunek, MD
role: PRINCIPAL_INVESTIGATOR
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