Premature Childbirth Clinical Trial
— EPIREMOfficial 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).
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | September 26, 2021 |
| Est. primary completion date | September 26, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 9 Years |
| Eligibility |
Inclusion Criteria: - Children born between 24 and 34 weeks of amenorrhea and living in the Provence region - Possessing an intelligence quotient (IQ) greater than 70 Exclusion Criteria: - Child not understanding French - Child who did not have all the interventions in the EPIREMED study |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Activation of cortical areas | Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory | 24 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04021485 -
BETAmethasone Dose Reduction: Non-Inferiority on the Neurocognitive Outcomes of Children Born Before 32 Weeks of Gestation
|
N/A |