{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T15:55:06Z","timestamp":1790697306378,"version":"4.1.0"},"reference-count":63,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,9,13]],"date-time":"2021-09-13T00:00:00Z","timestamp":1631491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,9,13]],"date-time":"2021-09-13T00:00:00Z","timestamp":1631491200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100004571","name":"minist\u00e8re des affaires sociales et de la sant\u00e9","doi-asserted-by":"publisher","award":["PHRC-15-626"],"award-info":[{"award-number":["PHRC-15-626"]}],"id":[{"id":"10.13039\/501100004571","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Pediatr"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Very preterm children generally perform poorly in executive functions and particularly in working memory. Adaptive training tasks encouraging these children to work continuously on their personal working memory capacity can be very useful. Above all in preschool-age children, several cognitive training programs focused on improving working memory capacity. Cogmed is a computerized visuospatial cognitive training program that improves working memory in children and adolescents with attention-deficit\/hyperactivity disorder. The main objective is to assess the long-term effects (18\u2009months) of cognitive training (Cogmed) on visuospatial processing in preschool-age very preterm children with working memory impairment.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The EPIREMED study is a prospective, randomized, controlled, multicentric trial nested in a population based epidemiological survey. An intervention group (Cogmed cognitive training) and a control group (standard care management) will compare children aged 5\u00bd to 6\u2009years, born between 24- and 34-weeks\u2019 gestational age, with a global intelligence quotient &gt;\u200970 and a working memory index &lt;\u200985. The study will include 166 children from national study EPIPAGE-2 (Epidemiological Study on Small Gestational Ages). The intervention consists of 25 sessions administered over a 5- to 8-week period. The primary endpoint will be the visuospatial processing, assessed by the score of the visuospatial index: score of the WPPSI-IV (Wechsler Preschool and Primary Scale of Intelligence). The secondary endpoints will allow to assess the executive functions, language and abilities, infant behavior, quality of life assessment, school performance and parental anxiety.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This project\u2019s primary goal is to demonstrate the necessity of early visuospatial memory assessment within the vulnerable population of very preterm children, and to prove the feasibility and efficacy of computerized cognitive training using online software programs. A better global neuropsychological development improvement (visuospatial processing and other far transfer) can be expected with an improvement in learning and decreased behavioral problems. In the long term, these improvements might also reduce those global costs linked to the consequences of extreme prematurity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT02757794?term=epiremed&amp;draw=2&amp;rank=1\">NCT02757794<\/jats:ext-link> (registered on 2nd May 2016 at ClinicalTrial.gov).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12887-021-02867-x","type":"journal-article","created":{"date-parts":[[2021,9,13]],"date-time":"2021-09-13T04:02:58Z","timestamp":1631505778000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory 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The sponsor and the investigators conduct the study in accordance with Good Clinical Practices and the French applicable regulatory requirements (Public Health Act No. 2004\u2013806 of August 9, 2004 on public health policy and its implementing decrees of August 27, 2006 [<i>Code de la Sant\u00e9 Publique, article L.1121\u20131<\/i>]), as the applicable privacy requirements and ethical principles outlined in the Declaration of Helsinki. This study was approved by the French Ethics Committee (<i>Comit\u00e9 de Protection des Personnes Sud M\u00e9diterran\u00e9e V<\/i>) on April 12, 2016 and by the French National Agency for Medicines and Health Products Safety (<i>Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9<\/i>) on April 18, 2016 (reference number ID-RCB:2016-A00122\u201349 \u2013 Protocol version 2 of 29 Mars 2016). All amendments will be submitted to these two French organizations and communicated to investigators associated by sponsor. The study was registered in ClinicalTrials.gov (NCT02757794).In accordance with applicable regulations including Good Clinical Practices, and Sponsor\u2019s procedures, a Sponsor\u2019s monitor will visit the investigator before, during and after the study. Sponsor\u2019s monitors will contact the site prior to the start of the study to review with the site staff the protocol, study requirements, and their responsibilities to satisfy regulatory, ethical, and Sponsor\u2019s requirements. When reviewing data collection procedures, the discussion will also include identification, agreement and documentation of data items for which the case report form will serve as the source document. The type and frequency of monitoring are determined using the definition of the level of monitoring based on patient risk and depend on the number of patients included, the rate of inclusions and difficulties encountered during the conduct of the study (procedures approved by the group quality promotion which determines the level of monitoring to be carried out based on risk to the subject-OECD recommendation on the Governance of Clinical Trials, December 2012). In this study, the level of monitoring is rated \u201cminimal\u201d with a risk for the patient level A. The Sponsor\u2019s monitor will verify the signed informed consents. If one \/ multiple consents are not compliant, files will be monitored randomly. All adverse events occurring during clinical trial have to be collected, verified, registered and reported from Day 0 (inclusion day for the participant) until the last day of the study, or as soon as the investigator becomes aware of the AE that he considers linked to the protocol and this up to its resolution.Any publication must state that <i>Assistance Publique - H\u00f4pitaux de Marseille<\/i> is the promoter and the study\u2019s databases will be co-owned by the promoter <i>Assistance Publique - H\u00f4pitaux de Marseille<\/i> and by the INSERM U1153, EPOP\u00c9 team. The results, as well as all research-related data, must under no circumstances be transmitted to third parties without compensation negotiated beforehand by the Medical Research Branch of the <i>Assistance Publique - H\u00f4pitaux de Marseille<\/i> and\/or INSERM U 1153.All data, results, inventions and discoveries resulting from the study will automatically become the exclusive property of the sponsor which may use this information in the manner deemed suitable with the agreement of the investigator.The EPIREMED study is part of EPIPAGE 2 and allows us to benefit from the collaboration of those involved in the EPIPAGE 2 cohort\u2019s steering committee. The different investigators are involved in the monitoring and care of very premature babies. Their diverse training and responsibilities meet all aspects of our project. These investigators are either pediatrician-neonatologists or pediatric neurologists working in type III neonatal units, in neuro-pediatric services for very premature infants\u2019s assessment or in a referral center for learning disabilities.A written informed consent will be obtained from two parents or legal representative to children participating in the study. Protection of the rights will be guaranteed, and anonymity maintained. In accordance with French laws and regulations respectively, all patient records identities will remain confidential. The study\u2019s results will be disseminated to patients via a written report in a clear and accessible language.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"402"}}