Evaluation of an Early Support Programme in Orthophony

Not Applicable

Terminated

• Conditions: Language Development Disorders; Preterm Birth
• Interventions: Other: Early Support Programme in Orthophony

• Registration Number: NCT04384328
• Lead Sponsor: Centre Hospitalier Sud Francilien

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.

Study Timeline

• Study Start: 2019-11-27
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-05-11
• Study First Posted: 2020-05-12
• Status Verified: 2022-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Last Update Submitted: 2023-02-15
• Last Update Posted: 2023-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Support Programme in Orthophony	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.

Primary Outcome Measures

Name	Time	Method
Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age.	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

Name	Time	Method
Score in the Ages & Stages Questionnaires communication domain at 12 and 18 months of corrected age.	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).
Failure rate of implementation of the early support program in speech-language pathology or early drop-out.	at 24 months of corrected age	Early drop-out is defined by 3 or less sessions.
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	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	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).

Trial Locations

Locations (4)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-Essonnes, France

Centre Hospitalier Louis Mourier; 🇫🇷 Colombes, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Centre Hospitalier Rives de Seine; 🇫🇷 Neuilly-sur-Seine, France