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Evaluation of an Early Support Programme in Orthophony

NCT04384328 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-02-17

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Centre Hospitalier Sud Francilien

    lead OTHER

Principal Investigators

  • Michèle Granier, MD · Centre Hospitalier Sud Francilien

  • Véronique Zupan-Simunek, MD · Hôpital Antoine Béclère

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-27
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384328 on ClinicalTrials.gov