Preterm BirthEPILANGNCT02042235
Very Preterm Children With Language Delay and Parent Intervention
A study testing Parent-implemented intervention in people with Preterm Birth and Language Development, run by Lille Catholic University at 15 sites in France.
Trial summary
In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. Read more about this study
- Who is it for?
- Ages 28 to 32 months
- Conditions the study is for
- Preterm Birth, Language Development, Speech Therapy
- What is being tested?
- Parent-implemented intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 15 sitesFrance
- Study dates
- Jan 2014to 31 Jan 2018
- 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 28 to 32 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
- Child aged 30 ± 2 months corrected age (CA) at inclusion
- Child with language delay at 24 months CA, defined as the absence of word combination and/or expressive vocabulary of less than 30 words according to the short version of the French Mac Arthur Communication Developmental Inventories (CDI), whose language delay is confirmed at 30 months CA i.e. without word combination and/or an expressive vocabulary below the 10th percentile on the French CDI.
- Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA
- Child whose parents accept participation in this study
- Child with French health insurance coverage
Who cannot join
- Child with neurological sequelae (delay or disability) and who is unable to walk without assistance at 24 months CA or who has a global DQ < 55 on the revised Brunet-Lézine (BLR) scale at 30 months CA.
- Blindness
- Deafness defined by the prescription of a hearing aid
- Child with a chromosomal or other condition that could interfere with language development
- Parents who do not speak French at all
- Triplets
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Centre Hospitalier
Arras, 62000
Centre Hospitalier Universitaire
Caen, 14000
Centre Hospitalier Universitaire
Lille, 59000
Hôpital Saint Vincent de Paul (GHICL)
Lille, 59000
Hôpital femme mère enfant
Lyon
Centre Hospitalier Universitaire
Marseille
Centre Hospitalier Universitaire
Nantes
AP-HP Hôpital Antoine Béclère
Paris
Hôpital Necker
Paris
HôpitalCochin - Port Royal
Paris
Centre Hospitalier
Roubaix, 59100
Centre hospitalier Universitaire
Rouen, 76000, 76100
Centre Hospitalier Universitaire
Strasbourg, 67000
Centre Hospitalier Universitaire
Tours, 37044
Centre Hospitalier
Valenciennes, 59300
About this study
Official title: Parent-implemented Intervention for Very Preterm Children With Language Delay
In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. However, for term-born children, parent-implemented language interventions conducted during the third year of life have already shown a positive short-term effect on language skills. In these interventions, a skilled interventionist, generally a speech therapist, teaches parents how to use specific language strategies with their child.
The investigators' hypothesis is that such parent-implemented interventions would be particularly appropriate at short and medium term for the improvement of linguistic performances in very preterm children, a population with a high prevalence of early language delay. Currently, there is an opportunity to partly nest an intervention trial in a national prospective population-based cohort of very preterm children, the EPIPAGE (Etude EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies born alive in France in 2011. This situation provides considerable methodological advantages.
Read the detailed description
EPILANG is an open randomized controlled study, in which the final assessment of the children (endpoint) will be conducted by professionals blinded to the treatment group.
Some eligible children will first be screened using the parental questionnaire at 24 months corrected age (CA) of the EPIPAGE 2 cohort. Children with language delay, defined as no words combination and/or less than 30 words from Mac Arthur CDI - short version, and free of exclusion criteria, will be invited to an inclusion visit at 30 months CA, if they are in an EPIPAGE 2 centre participating in the EPILANG trial.
During the inclusion visit, inclusion criteria and the absence of exclusion criteria will be checked, data useful for the study will be collected, and the informed consent of the parents collected. The child will then be randomized either in the control or the intervention group if language delay is still present, defined by a score < 10th percentile at the Mac Arthur CDI. Twins, if both included, will be included in the same group, otherwise only the twin with a language delay will be randomized.
The intervention is organized in 15 weekly one-hour sessions with the child, one or both parents and a speech therapist recruited and trained for the study. Maximum duration for the intervention will be 6 months per child, because some sessions can be missed or delayed. Parents' participation will be recorded.
The usual "wait-and-see" attitude will be provided to the control group, together with basic advice to enhance the child's language at home.
In both groups, audition will be checked by an otolaryngology specialist, following professional recommendations, and care will be provided in case of hearing deficit, if appropriate.
At 3 years CA, a neuropsychological evaluation will be performed by trained psychologists for both groups, blinded for the allocation group. Behaviour will be evaluated with a validated parental questionnaire.
The analysis will be according to intention to treat.
- Conditions
- Preterm Birth, Language Development, Speech Therapy
- Being tested
- Parent-implemented intervention
- Keywords
- prematurity, language, parent-implemented intervention, speech therapy, neurodevelopment
- Medical subject headings
- Premature Birth, Communication Disorders, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-implemented interventionBehavioural
In order to achieve the programme of parent-implemented language intervention, a detailed protocol for speech therapists recruited and trained for the present study has been established. The techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child.
| Study group | Role | What they receive |
|---|---|---|
| Parent-implemented language intervention | Experimental | In the intervention group, the techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child. Receives: Behavioral: Parent-implemented intervention |
| Control group | No intervention | The control group will benefit from the actual routine care for children with language delay before the age of 3 years. In order to provide them the best routine care, the psychologist will provide some advice to the parents to enhance their child's language (e.g.: using life situations to talk with the child and encourage him/her to talk …). |
What is being measured
The primary outcome is the main question the study is designed to answer.
language score of the Developmental Neuropsychological assessment (NEPSY)
For the main outcome, mean language score on the NEPSY at the final visit, our primary endpoint, will be compared between groups using linear regression
Measured: at 36 months of corrected age
Secondary outcomes (3)
Other scores of the NEPSY battery
To evaluate the child's neuropsychological functioning
Measured: at 36 months of corrected age
Strengths and Difficulties Questionnaire
Measured: at 36 months of corrected age
Parenting Stress Index (PSI) questionnaire
Measured: at 36 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 posted22 Jan 2014 (estimated)
- Study startJan 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Why it stopped: difficulted recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Amélie Lansiaux, MD, PhD, Study chair, Groupment des Hôpitaux de l'Institut Catholique de LilleMarie-Laure Charkaluk, MD, PhD, Study director, Hôpital Saint-Vincent-de-Paul, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042235
- Sponsor's protocol ID
- RC-P0027
- Acronym
- EPILANG
- Status last verified
- Mar 2020
- First submitted
- 20 Jan 2014
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-implemented Intervention for Very Preterm Children With Language Delay
- ClinicalTrials.gov ID
- NCT02042235
- Acronym / sponsor ID
- EPILANG / RC-P0027
- Conditions
- Preterm Birth, Language Development, Speech Therapy
- Keywords
- prematurity, language, parent-implemented intervention, speech therapy, neurodevelopment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulted recruiting
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2014
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 22 Jan 2014 (estimated)
- 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.
In studies of children born at term, language delay at the age of 2 years exhibits a spontaneously favourable course in 30 to 50% by the age of 3 years. In France, there is no recommendation for speech therapy before the age of 3 years. However, for term-born children, parent-implemented language interventions conducted during the third year of life have already shown a positive short-term effect on language skills. In these interventions, a skilled interventionist, generally a speech therapist, teaches parents how to use specific language strategies with their child.
The investigators' hypothesis is that such parent-implemented interventions would be particularly appropriate at short and medium term for the improvement of linguistic performances in very preterm children, a population with a high prevalence of early language delay. Currently, there is an opportunity to partly nest an intervention trial in a national prospective population-based cohort of very preterm children, the EPIPAGE (Etude EPIdémiologique sur les Petits Ages GEstationnels) 2 cohort, which has included 5 000 babies born alive in France in 2011. This situation provides considerable methodological advantages.
Detailed description
EPILANG is an open randomized controlled study, in which the final assessment of the children (endpoint) will be conducted by professionals blinded to the treatment group.
Some eligible children will first be screened using the parental questionnaire at 24 months corrected age (CA) of the EPIPAGE 2 cohort. Children with language delay, defined as no words combination and/or less than 30 words from Mac Arthur CDI - short version, and free of exclusion criteria, will be invited to an inclusion visit at 30 months CA, if they are in an EPIPAGE 2 centre participating in the EPILANG trial.
During the inclusion visit, inclusion criteria and the absence of exclusion criteria will be checked, data useful for the study will be collected, and the informed consent of the parents collected. The child will then be randomized either in the control or the intervention group if language delay is still present, defined by a score < 10th percentile at the Mac Arthur CDI. Twins, if both included, will be included in the same group, otherwise only the twin with a language delay will be randomized.
The intervention is organized in 15 weekly one-hour sessions with the child, one or both parents and a speech therapist recruited and trained for the study. Maximum duration for the intervention will be 6 months per child, because some sessions can be missed or delayed. Parents' participation will be recorded.
The usual "wait-and-see" attitude will be provided to the control group, together with basic advice to enhance the child's language at home.
In both groups, audition will be checked by an otolaryngology specialist, following professional recommendations, and care will be provided in case of hearing deficit, if appropriate.
At 3 years CA, a neuropsychological evaluation will be performed by trained psychologists for both groups, blinded for the allocation group. Behaviour will be evaluated with a validated parental questionnaire.
The analysis will be according to intention to treat.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-implemented language intervention | Experimental | Behavioral: Parent-implemented interventionIn the intervention group, the techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child. |
| Control group | No intervention | –The control group will benefit from the actual routine care for children with language delay before the age of 3 years. In order to provide them the best routine care, the psychologist will provide some advice to the parents to enhance their child's language (e.g.: using life situations to talk with the child and encourage him/her to talk …). |
Who may qualify
- Ages
- 28 to 32 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child born at 24 to 31+6 weeks' gestation, whose parents did not refuse collection of follow-up data
- Child aged 30 ± 2 months corrected age (CA) at inclusion
- Child with language delay at 24 months CA, defined as the absence of word combination and/or expressive vocabulary of less than 30 words according to the short version of the French Mac Arthur Communication Developmental Inventories (CDI), whose language delay is confirmed at 30 months CA i.e. without word combination and/or an expressive vocabulary below the 10th percentile on the French CDI.
- Child with a global Developmental Quotient (DQ) ≥ 55 at 30 months CA
- Child whose parents accept participation in this study
Key exclusion criteria (6 listed)
- Child with neurological sequelae (delay or disability) and who is unable to walk without assistance at 24 months CA or who has a global DQ < 55 on the revised Brunet-Lézine (BLR) scale at 30 months CA.
- Blindness
- Deafness defined by the prescription of a hearing aid
- Child with a chromosomal or other condition that could interfere with language development
- Parents who do not speak French at all
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 |
|---|---|---|
| Parent-implemented interventionIn order to achieve the programme of parent-implemented language intervention, a detailed protocol for speech therapists recruited and trained for the present study has been established. The techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child. | Behavioural | Parent-implemented language intervention |
Primary outcome
language score of the Developmental Neuropsychological assessment (NEPSY)
Time frame: at 36 months of corrected age
For the main outcome, mean language score on the NEPSY at the final visit, our primary endpoint, will be compared between groups using linear regression
3 secondary outcomes
Other scores of the NEPSY battery
Time frame: at 36 months of corrected age
Strengths and Difficulties Questionnaire
Time frame: at 36 months of corrected age
Parenting Stress Index (PSI) questionnaire
Time frame: at 36 months of corrected age
Results and safety
The study was stopped early (reason given: difficulted recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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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.
Amélie Lansiaux, MD, PhD study chair
Groupment des Hôpitaux de l'Institut Catholique de Lille
Marie-Laure Charkaluk, MD, PhD study director
Hôpital Saint-Vincent-de-Paul, GHICL
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-implemented intervention in people with Preterm Birth and Language Development, run by Lille Catholic University at 15 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 6 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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: difficulted recruiting). 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?
language score of the Developmental Neuropsychological assessment (NEPSY) (time frame: at 36 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 3 Mar 2020.