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

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ClinicalTrials.gov Identifier: NCT04384328
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Collaborator:
Réseau Pédiatrique du Sud et Ouest Francilien - Association pour Suivi des Nouveau-nés à Risque
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Language Development Disorders Preterm Birth Other: Early Support Programme in Orthophony Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : November 26, 2021
Estimated Study Completion Date : November 26, 2023

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. 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).



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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04384328


Contacts
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Contact: Elodie Henry, CRU manager +33161693730 elodie.henry@chsf.fr

Locations
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France
Hôpital Antoine Béclère Recruiting
Clamart, France, 92141
Contact: Véronique Zupan Simunek, MD    +33145374429    Veronique.zupan@aphp.fr   
Centre Hospitalier Louis Mourier Recruiting
Colombes, France, 92700
Contact: Florence Cholley Delmas, MD    +33147606744    Florence.cholley-delmas@aphp.fr   
Centre Hospitalier Sud Francilien Recruiting
Corbeil-Essonnes, France, 91100
Contact: Michèle Granier, MD    +33161697808    michele.granier@chsf.fr   
Centre Hospitalier Rives de Seine Recruiting
Neuilly-sur-Seine, France, 92200
Contact: Patricia Dworzak Ropert, MD    +33146247881    Patricia.dworzak-ropert@orange.fr   
Sponsors and Collaborators
Centre Hospitalier Sud Francilien
Réseau Pédiatrique du Sud et Ouest Francilien - Association pour Suivi des Nouveau-nés à Risque
Investigators
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Study Director: Michèle Granier, MD Centre Hospitalier Sud Francilien
Principal Investigator: Véronique Zupan-Simunek, MD Hôpital Antoine Béclère
Publications of Results:

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Responsible Party: Centre Hospitalier Sud Francilien
ClinicalTrials.gov Identifier: NCT04384328    
Other Study ID Numbers: 2018-A01898-47
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Sud Francilien:
language Development
communication Development
preterm infant
orthophony
Additional relevant MeSH terms:
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Language Development Disorders
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms