Infant, PrematureLAMOPRESCO2NCT02811029
Language and Motricity in Preterm School Age Children
A study testing measurement of phonology in people with Infant, Premature, run by University Hospital, Rouen at 1 site in France.
Trial summary
A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure. Read more about this study
- Who is it for?
- Ages 8 to 8 years
- Conditions the study is for
- Infant, Premature
- What is being tested?
- measurement of phonology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2016to 11 Dec 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 8 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Randomization in LAMOPRESCO-1 study
Who cannot join
- None as the same population as in the LAMOPRESCO study will be included
Trial locations and contacts
1 site in 1 country.
About this study
A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure.
Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders, executive function disorders as well as attention and behaviour disorders. Developmental language disorders have been rarely reported in the literature. This originally prompted our request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol has studied the language development of children who were born very prematurely, aged 3 and a half years free of cerebral palsy, in particular the impact of a short rehabilitation period, precise, at an early stage, and protocolized on a fundamental sensorimotor language. The principal assessment criterion was the measurement of phonology, the cornerstone of oral and written language in humans. The aim of the present project is an analysis of the effect that this specific language stimulation has on the learning of written language. The hypothesis is that a specific work modifying various aspects of a child's language, during the age of 3 to 4, alters the development of phonological skills in a sustainable way. The acquisition of reading skills is basically dependent on the quality of its phonological components. The randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing difficulties have been reported as regards the language understanding of 3 to 15 year old children. It is as if the initial difficulties and weaknesses, which moreover constituted oral language, prevented the use or development of neural networks, which became more complex and required both an oral and written language. Are these elements which constitute phonology, at an early stage, modifiable before the close of the clinically measurable developmental window?
- Conditions
- Infant, Premature
- Being tested
- measurement of phonology
- Keywords
- neurological, difficulties
- Medical subject headings
- Premature Birth, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of phonologyBehavioural
measurement of phonology will be assess using BILO-3, EDA, VS and VL tests
| Study group | Role | What they receive |
|---|---|---|
| premature infants less than 32 weeks of age | Experimental | measurement of phonology in premature infants less than 32 weeks of age who participated to LAMOPRESCO-1 study Receives: Behavioral: measurement of phonology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of reading speed
Evaluation of reading speed will be assess using silent reading speed test. Patient must read a list of words during 2 minutes. The total number of read words will be analyse to calculate the reading speed.
Measured: Day 1
Secondary outcomes (3)
Evaluation of syntax level
Patient must read a list of words during 2 minutes and select how much words are not correctly written.
Measured: Day 1
Evaluation of vocabulary level, syntax and understanding
Patient must read a list of words during 2 minutes and select how much words are not correctly written.
Measured: Day 1
Evaluation of understanding level
Patient must read a text and then answer oral questions about the history read.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start29 Jun 2016
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Why it stopped: Difficulty in enrolling patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aude CHAROLLAIS, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811029
- Sponsor's protocol ID
- 2015/207/HP
- Acronym
- LAMOPRESCO2
- Status last verified
- Apr 2026
- First submitted
- 15 Jun 2016
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language and Motricity in Preterm School Age Children
- ClinicalTrials.gov ID
- NCT02811029
- Acronym / sponsor ID
- LAMOPRESCO2 / 2015/207/HP
- Conditions
- Infant, Premature
- Keywords
- neurological, difficulties
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling patients
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 23 Jun 2016 (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.
A total of 40% of neurodevelopmental difficulties have been reported in very premature infants less than 32 weeks of age. The Epipage1 study reported a decreasing prevalence of cerebral palsy (9-6%) but a high prevalence of specific cognitive neurological difficulties and an increase in school failure.
Neurocognitive difficulties are numerous: visuospatial dyspraxia, language disorders, executive function disorders as well as attention and behaviour disorders. Developmental language disorders have been rarely reported in the literature. This originally prompted our request i.e. PHRC 2010 National Multicenter: LAMOPRESCO. For the past 3 years this protocol has studied the language development of children who were born very prematurely, aged 3 and a half years free of cerebral palsy, in particular the impact of a short rehabilitation period, precise, at an early stage, and protocolized on a fundamental sensorimotor language. The principal assessment criterion was the measurement of phonology, the cornerstone of oral and written language in humans. The aim of the present project is an analysis of the effect that this specific language stimulation has on the learning of written language. The hypothesis is that a specific work modifying various aspects of a child's language, during the age of 3 to 4, alters the development of phonological skills in a sustainable way. The acquisition of reading skills is basically dependent on the quality of its phonological components. The randomized study of children up to 8 years of age in a cohort of 150 children (LAMOPRESCO) will permit to confirm or refute this hypothesis. These increasing difficulties have been reported as regards the language understanding of 3 to 15 year old children. It is as if the initial difficulties and weaknesses, which moreover constituted oral language, prevented the use or development of neural networks, which became more complex and required both an oral and written language. Are these elements which constitute phonology, at an early stage, modifiable before the close of the clinically measurable developmental window?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature infants less than 32 weeks of age | Experimental | Behavioral: measurement of phonologymeasurement of phonology in premature infants less than 32 weeks of age who participated to LAMOPRESCO-1 study |
Who may qualify
- Ages
- 8 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Randomization in LAMOPRESCO-1 study
Key exclusion criteria (1 listed)
- None as the same population as in the LAMOPRESCO study will be included
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 |
|---|---|---|
| measurement of phonologymeasurement of phonology will be assess using BILO-3, EDA, VS and VL tests | Behavioural | premature infants less than 32 weeks of age |
Primary outcome
Evaluation of reading speed
Time frame: Day 1
Evaluation of reading speed will be assess using silent reading speed test. Patient must read a list of words during 2 minutes. The total number of read words will be analyse to calculate the reading speed.
3 secondary outcomes
Evaluation of syntax level
Time frame: Day 1
Evaluation of vocabulary level, syntax and understanding
Time frame: Day 1
Evaluation of understanding level
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Difficulty in enrolling patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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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.
Aude CHAROLLAIS, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of phonology in people with Infant, Premature, run by University Hospital, Rouen at 1 site 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 1 inclusion and 1 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 4 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 1 site 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: Difficulty in enrolling patients). 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?
Evaluation of reading speed (time frame: Day 1). 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 4 May 2026.