Evaluation of an Early Support Programme in Orthophony

NCT04384328 | Terminated DMC

• 1 other identifier: 2018-A01898-47
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 4

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.

Conditions

Language Development Disorders; Preterm Birth

Keywords

language Development; communication Development; preterm infant; orthophony

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Failure rate of implementation of the early support program in speech-language pathology or early drop-out.

  at 24 months of corrected age

• Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.

  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

  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

  at 12 and 24 months of corrected age

Study Arms (2)

Early Support Programme in Orthophony

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions.

Interventions

Early Support Programme in Orthophony OTHER

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.

Early Support Programme in Orthophony

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Premature birth \< 32 weeks of amenorrhea
• or premature birth with intrauterine growth restriction (IUGR) \< P3
• affiliation to a social security system + mutual insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (4)

Hôpital Antoine Béclère

Clamart, 92141, France

Location

Centre Hospitalier Louis Mourier

Colombes, 92700, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91100, France

Location

Centre Hospitalier Rives de Seine

Neuilly-sur-Seine, 92200, France

Location

MeSH Terms

Conditions

Language Development Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Michèle Granier, MD

  Centre Hospitalier Sud Francilien

  STUDY DIRECTOR

• Véronique Zupan-Simunek, MD

  Hôpital Antoine Béclère

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: May 12, 2020
• Study Start: November 27, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

FR (4)