Premature ChildbirthEPIREMNCT03972761
Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive Remediation
A study testing Magnetic Resonance Imaging (MRI) 3 tesla in people with Premature Childbirth, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives. Read more about this study
- Who is it for?
- Ages 8 to 9 years
- Conditions the study is for
- Premature Childbirth
- What is being tested?
- Magnetic Resonance Imaging (MRI) 3 tesla
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2019to 26 Sep 2021
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children born between 24 and 34 weeks of amenorrhea and living in the Provence region
- Possessing an intelligence quotient (IQ) greater than 70
Who cannot join
- Child not understanding French
- Child who did not have all the interventions in the EPIREMED study
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Barthélémy TOSELLO, PH, 491968300 ext. +33, barthelemy.tosello@ap-hm.fr
Barthélémy TOSELLO, PH
About this study
Official title: Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives.
In addition, generally very premature infants (TGP) have identifiable executive function disorders (EF), particularly those involving attentional processes such as working memory (WM).
Read more
The main objective of the study is to evaluate the effects of cognitive remediation (CR) strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children (8 years).
The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned
It is a monocentric, prospective and comparative study of the exposed type (to cognitive remediation) - unexposed. Recruitment and data collection are carried out prospectively, in connection with the original study (EPIREMED). Included patients will be explored by Magnetic Resonance Imaging (MRI) 3 resting state Tesla.
The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions, but also on the cortical areas involved in brain plasticity in general (indirect benefits); not to mention the psychological benefits ad hoc to such studies (self-esteem, increased concentration, new stress management strategies put in place).
The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions. Moreover, this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders. Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future.
- Conditions
- Premature Childbirth
- Being tested
- Magnetic Resonance Imaging (MRI) 3 tesla
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI) 3 teslaDevice
Functional neuroimaging objectifies the activation of specific areas of the brain
| Study group | Role | What they receive |
|---|---|---|
| Group exposed to cognitive remediation | Active comparator | Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794) Receives: Device: Magnetic Resonance Imaging (MRI) 3 tesla |
| Group not exposed to cognitive remediation | Placebo comparator | Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794) Receives: Device: Magnetic Resonance Imaging (MRI) 3 tesla |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation of cortical areas
Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start27 Sep 2019 (estimated)
- Primary completion26 Sep 2021 (estimated)
- Study completion26 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature ChildbirthStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972761
- Sponsor's protocol ID
- 2019-07
- Other IDs
- 2019-A00829-48, RCAPHM19_0023
- Acronym
- EPIREM
- Status last verified
- May 2019
- First submitted
- 31 May 2019
- Last updated
- 4 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
- ClinicalTrials.gov ID
- NCT03972761
- Acronym / sponsor ID
- EPIREM / 2019-07
- Conditions
- Premature Childbirth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 27 Sep 2019 (estimated)
- Primary completion
- 26 Sep 2021 (estimated)
- Study completion
- 26 Sep 2021 (estimated)
- First posted
- 4 Jun 2019 (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.
Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives.
In addition, generally very premature infants (TGP) have identifiable executive function disorders (EF), particularly those involving attentional processes such as working memory (WM).
The main objective of the study is to evaluate the effects of cognitive remediation (CR) strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children (8 years).
The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned
It is a monocentric, prospective and comparative study of the exposed type (to cognitive remediation) - unexposed. Recruitment and data collection are carried out prospectively, in connection with the original study (EPIREMED). Included patients will be explored by Magnetic Resonance Imaging (MRI) 3 resting state Tesla.
The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions, but also on the cortical areas involved in brain plasticity in general (indirect benefits); not to mention the psychological benefits ad hoc to such studies (self-esteem, increased concentration, new stress management strategies put in place).
The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions. Moreover, this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders. Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group exposed to cognitive remediation | Active comparator | Device: Magnetic Resonance Imaging (MRI) 3 teslaComputerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794) |
| Group not exposed to cognitive remediation | Placebo comparator | Device: Magnetic Resonance Imaging (MRI) 3 teslaStandard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794) |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children born between 24 and 34 weeks of amenorrhea and living in the Provence region
- Possessing an intelligence quotient (IQ) greater than 70
Key exclusion criteria (2 listed)
- Child not understanding French
- Child who did not have all the interventions in the EPIREMED study
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI) 3 teslaFunctional neuroimaging objectifies the activation of specific areas of the brain | Device | Group exposed to cognitive remediation, Group not exposed to cognitive remediation |
Primary outcome
Activation of cortical areas
Time frame: 24 months
Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- 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.
Jean-Olivier ARNAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) 3 tesla in people with Premature Childbirth, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2019. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barthélémy TOSELLO, PH (491968300 ext. +33, barthelemy.tosello@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation of cortical areas (time frame: 24 months). 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 Jun 2019.