Evaluation of an Early Support Programme in Orthophony

Status Terminated

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04384328
Study type	Interventional
Source	Centre Hospitalier Sud Francilien
Contact
Status	Terminated
Phase	N/A
Start date	November 27, 2019
Completion date	December 31, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of an Early Support Programme in Orthophony — PAPEV-ortho

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms