Evaluation of an Early Support Programme in Orthophony (PAPEV-ortho)

February 15, 2023 updated by: Centre Hospitalier Sud Francilien

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clamart, France, 92141
        • Hôpital Antoine Béclère
      • Colombes, France, 92700
        • Centre Hospitalier Louis Mourier
      • Corbeil-Essonnes, France, 91100
        • Centre Hospitalier Sud Francilien
      • Neuilly-sur-Seine, France, 92200
        • Centre Hospitalier Rives de Seine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: Standard Care
Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate of implementation of the early support program in speech-language pathology or early drop-out.
Time Frame: at 24 months of corrected age
Early drop-out is defined by 3 or less sessions.
at 24 months of corrected age
Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.
Time Frame: at 12 and 18 months of corrected age.
The Ages & Stages Questionnaires is a parental questionnaire that is strongly correlated with traditional developmental tests. The Ages & Stages Questionnaires communication domain takes into account receptive and expressive language, includes 6 questions, and ranges from 0 (worst) to 60 (best).
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
Time Frame: at 12, 18 and 24 months of corrected age
The IFDC questionnaire is a recommended tool for monitoring and early detection of language deficits. It is expressed as a percentile (0=worst, 100=best).
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
Time Frame: at 12 and 24 months of corrected age
The Communication and Symbolic Behavior Scales qestionnaire is a tool for screening for communication disorders and interactions. It ranges from 0 (worst) tro 57 (best).
at 12 and 24 months of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Véronique Zupan-Simunek, MD, Hôpital Antoine Béclère

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 12, 2020

Study Record Updates

Last Update Posted (Actual)

February 17, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A01898-47

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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