Evaluation of an Early Support Programme in Orthophony (PAPEV-ortho)
Primary Purpose
Language Development Disorders, Preterm Birth
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Early Support Programme in Orthophony
Sponsored by
About this trial
This is an interventional prevention trial for Language Development Disorders focused on measuring language Development, communication Development, preterm infant, orthophony
Eligibility Criteria
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
Sites / Locations
- Hôpital Antoine Béclère
- Centre Hospitalier Louis Mourier
- Centre Hospitalier Sud Francilien
- Centre Hospitalier Rives de Seine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early Support Programme in Orthophony
Standard Care
Arm Description
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.
Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Failure rate of implementation of the early support program in speech-language pathology or early drop-out.
Early drop-out is defined by 3 or less sessions.
Score in the Ages & Stages Questionnaires communication domain 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).
score at Inventaire Français du Développement Communicatif questionnaire 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).
Score at Communication and Symbolic Behavior Scales questionnaire 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).
Full Information
NCT ID
NCT04384328
First Posted
February 6, 2020
Last Updated
February 15, 2023
Sponsor
Centre Hospitalier Sud Francilien
1. Study Identification
Unique Protocol Identification Number
NCT04384328
Brief Title
Evaluation of an Early Support Programme in Orthophony
Acronym
PAPEV-ortho
Official Title
Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
rate of inclusions too low
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Sud Francilien
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Language Development Disorders, Preterm Birth
Keywords
language Development, communication Development, preterm infant, orthophony
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Support Programme in Orthophony
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions.
Intervention Type
Other
Intervention Name(s)
Early Support Programme in Orthophony
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.
Description
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
Time Frame
at 24 months of corrected age
Secondary Outcome Measure Information:
Title
Failure rate of implementation of the early support program in speech-language pathology or early drop-out.
Description
Early drop-out is defined by 3 or less sessions.
Time Frame
at 24 months of corrected age
Title
Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.
Description
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).
Time Frame
at 12 and 18 months of corrected age.
Title
score at Inventaire Français du Développement Communicatif questionnaire at 12, 18 and 24 months of corrected age
Description
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).
Time Frame
at 12, 18 and 24 months of corrected age
Title
Score at Communication and Symbolic Behavior Scales questionnaire at 12 and 24 months of corrected age
Description
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).
Time Frame
at 12 and 24 months of corrected age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle Granier, MD
Organizational Affiliation
Centre Hospitalier Sud Francilien
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Véronique Zupan-Simunek, MD
Organizational Affiliation
Hôpital Antoine Béclère
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
Centre Hospitalier Louis Mourier
City
Colombes
ZIP/Postal Code
92700
Country
France
Facility Name
Centre Hospitalier Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Centre Hospitalier Rives de Seine
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
12. IPD Sharing Statement
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Evaluation of an Early Support Programme in Orthophony
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