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

Centre Hospitalier Sud Francilien

Status: Terminated

Conditions: Preterm Birth; Language Development Disorders

Treatments: Other: Early Support Programme in Orthophony

Study type: Interventional

Funder types: Other

Identifiers

NCT04384328

2018-A01898-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Early Support Programme in Orthophony

Experimental group

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.

Treatment:

Other: Early Support Programme in Orthophony

Standard Care

No Intervention group

Description:

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