NCT04384328

Evaluation of an Early Support Programme in Orthophony

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Centre Hospitalier Sud Francilien · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Language Development Disorders
• Preterm Birth

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-11-27
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-05-12
• Last updated: 2023-02-17

Locations

4 sites across 1 country: France