Language Development DisordersPAPEV-orthoNCT04384328
Evaluation of an Early Support Programme in Orthophony
A study testing Early Support Programme in Orthophony in people with Language Development Disorders and Preterm Birth, run by Centre Hospitalier Sud Francilien at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Language Development Disorders, Preterm Birth
- What is being tested?
- Early Support Programme in Orthophony
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 4 sitesFrance
- Study dates
- 27 Nov 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Antoine Béclère
Clamart, 92141
Centre Hospitalier Louis Mourier
Colombes, 92700
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91100
Centre Hospitalier Rives de Seine
Neuilly-sur-Seine, 92200
About this study
Official title: Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study
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.
Read the 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.
- Conditions
- Language Development Disorders, Preterm Birth
- Being tested
- Early Support Programme in Orthophony
- Keywords
- language Development, communication Development, preterm infant, orthophony
- Medical subject headings
- Language Development Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Support Programme in OrthophonyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Support Programme in Orthophony | Experimental | 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. Receives: Other: Early Support Programme in Orthophony |
| Standard Care | No intervention | Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 24 months of corrected age
Secondary outcomes (4)
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.
Measured: at 24 months of corrected age
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).
Measured: at 12 and 18 months of corrected age.
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).
Measured: at 12, 18 and 24 months of corrected age
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).
Measured: at 12 and 24 months of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start27 Nov 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: rate of inclusions too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle Granier, MD, Study director, Centre Hospitalier Sud FrancilienVéronique Zupan-Simunek, MD, Principal investigator, Hôpital Antoine Béclère
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384328
- Sponsor's protocol ID
- 2018-A01898-47
- Acronym
- PAPEV-ortho
- Status last verified
- May 2026
- First submitted
- 6 Feb 2020
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Early Support Programme in Orthophony : the PAPEV-ortho Study
- ClinicalTrials.gov ID
- NCT04384328
- Acronym / sponsor ID
- PAPEV-ortho / 2018-A01898-47
- Conditions
- Language Development Disorders, Preterm Birth
- Keywords
- language Development, communication Development, preterm infant, orthophony
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: rate of inclusions too low
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, interventionnal with minimal risks and constraints, multicentric, non-randomized, open study.
| Arm | Type | Receives |
|---|---|---|
| Early Support Programme in Orthophony | Experimental | Other: Early Support Programme in OrthophonyEarly 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 Care | No intervention | –Standard follow-up within the RPSOF-ASNR network, without systematic speech therapy sessions. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Support Programme in OrthophonyEarly 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 |
Primary outcome
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
4 secondary outcomes
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
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.
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
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
Results and safety
The study was stopped early (reason given: rate of inclusions too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michèle Granier, MD study director
Centre Hospitalier Sud Francilien
Véronique Zupan-Simunek, MD principal investigator
Hôpital Antoine Béclère
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Support Programme in Orthophony in people with Language Development Disorders and Preterm Birth, run by Centre Hospitalier Sud Francilien at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: rate of inclusions too low). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score in the Ages & Stages Questionnaires communication domain at 24 months of corrected age. (time frame: at 24 months of corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.