Children Born Extremely Premature Clinical Trial
— EPIREMEDOfficial title:
Long-term Effects of Visual Spatial Working Memory Training Program Performed at Preschool Age in Very Preterm Infants With Visual Spatial Working Memory Deficit. A Randomized Controlled Trial
| Verified date | July 2023 |
| Source | Assistance Publique Hopitaux De Marseille |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Prematurity tends to increase in France in recent years and more children born extremely premature infants survive. If severe impairments have stabilized, the majority of former extremely premature children have neuropsychological disorders and moderate appearance behavior disorder, but with a significant impact both family, school and social persisting into adulthood. Executive functions (EF), in general, and working memory (MT), in particular, are frequently altered in older children preterm infants compared to controls born at term. The identification process of loss in certain diseases, as well as improving knowledge of brain functioning, and development with the possibility of neuronal plasticity has led research teams to develop intervention programs focused on process cognitive qualified of "remediation" cognitive (RC). Schematically, the RC is defined as a rehabilitation or altered cognitive functions. MT can be improved by encouraging the operation of the spots mental stimulant. These programs are effective on MT but do not have the expected impact on other FE, language or nonverbal functions (visuospatial). The functional benefit of cognitive remediation remains controversial. Improving mental functions untrained as nonverbal MT, attention and secondarily learning is possible but still unproven on wide population. Similarly, randomized trials are needed to test this type of cognitive remediation among preschoolers old very premature.
| Status | Completed |
| Enrollment | 166 |
| Est. completion date | August 20, 2019 |
| Est. primary completion date | August 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 5 Years to 6 Years |
| Eligibility | Inclusion Criteria: - Already included in the study EPIPAGE 2, born between 24 and 34 weeks' GA (gestational amenorrhea), - Children aged 5 to 6 years, - Children exhibiting a total intellectual quotient >70 from the WPPSI IV (during the 5-year assessment in EPIPAGE 2), - Children having a visuo-spatial Working Memory impairment defined by a working memory index <85 from the WPPSI IV, - Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form, - Children affiliated with medical insurance. Exclusion Criteria: - Children with severe cerebral palsy, based on the Gross Motor Function (GMFCS score >2) and Bimanual Fine Motor Function (BFMF >2) classification system (Elvrum AG 2015, Marois P 2015), - Children with blindness or amblyopia, defined by a visual acuity <3 (during the 5-year assessment in EPIPAGE 2), - Children with deafness, as defined by a prescribed hearing aid, - Children with chromosomal disorder or autistic syndrome, - Children included in the EPILANG study protocol (an ancillary project to EPIPAGE), - Children who do not speak French - Children with parents having no internet connection, - Triplets. |
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital of Lyon | Bron | |
| France | University Hospital of Caen Normandie | Caen | |
| France | University Hospital of Clermont-Ferrand | Clermont-Ferrand | |
| France | Sud Francilien Hospital | Corbeil-Essonnes | |
| France | University Hospital of Grenoble | Grenoble | |
| France | Assistance Publique Hôpitaux de Marseille | Marseille | |
| France | University Hospital of Montpellier | Montpellier | |
| France | Regional University Hospital of Nancy | Nancy | |
| France | University Hospital of Nantes | Nantes | |
| France | University Hospital of Nice | Nice | |
| France | University Hospital of Nîmes | Nîmes | |
| France | AP- HP - Armand Trousseau Hospital | Paris | |
| France | University Hospital of Reims | Reims | |
| France | University Hospital of Rouen | Rouen | |
| France | University Hospital of Saint-Etienne | St Etienne | |
| France | Regional University Hospital of Strasbourg | Strasbourg | |
| France | University Hospital of Toulouse | Toulouse | |
| France | University Hospital of Tour | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Increase of the measuring index visuospatial | This index consists of two subtests : block design and object assembly. The average score is 100 with a standard deviation of 15. | 18 months (more or less 2 months) post inclusion | |
| Secondary | Assessment of intellectual functioning | award of global IQ | 8 months (more or less 2 months) post inclusion | |
| Secondary | Evaluation of the working memory | administering the questionnaire Wechsler Preschool and Primary Scale of Intelligence (WPPSI IV) | 18 months (more or less 2 months) post inclusion | |
| Secondary | evaluation of neuropsychological development of children | award of Neuropsychological Assessment test (NEPSY) | 8 months (more or less 2 months) post inclusion | |
| Secondary | Evaluation of language and skills | passing the test Communicate, Learn to Read and Write (KEY) | 8 months (more or less 2 months) post inclusion | |
| Secondary | Rating behavior | award of Goodman questionnaire (Strengths and Difficulties Questionnaire (SDQ)) | 8 months (more or less 2 months) post inclusion | |
| Secondary | Evaluation of parental anxiety | award of Spielberger Trait Anxiety Inventory questionnaire | 8 months (more or less 2 months) post inclusion | |
| Secondary | Assessing the quality of a child's life | Quality of Life Questionnaire | 8 months (more or less 2 months) post inclusion | |
| Secondary | Evaluation of Education | Evaluation of Education is evaluated by the global adaptation school score (GSA) survey | 8 months (more or less 2 months) post inclusion |