Status:

TERMINATED

Evaluation of an Early Support Programme in Orthophony

Lead Sponsor:

Centre Hospitalier Sud Francilien

Conditions:

Language Development Disorders

Preterm Birth

Eligibility:

All Genders

Up to 6 years

Phase:

NA

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 vulner...

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 vulner...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 27 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

76 Patients enrolled

Trial Details

Trial ID

NCT04384328

Start Date

November 27 2019

End Date

December 31 2022

Last Update

February 17 2023

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Hôpital Antoine Béclère

Clamart, France, 92141

2

Centre Hospitalier Louis Mourier

Colombes, France, 92700

3

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91100

4

Centre Hospitalier Rives de Seine

Neuilly-sur-Seine, France, 92200