A randomized EPIREMED protocol study on the long-term visuo spatial effects of very preterm children with a working memory deficit.


Journal

BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804

Informations de publication

Date de publication:
13 09 2021
Historique:
received: 16 07 2021
accepted: 18 08 2021
entrez: 14 9 2021
pubmed: 15 9 2021
medline: 26 10 2021
Statut: epublish

Résumé

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 months) of cognitive training (Cogmed) on visuospatial processing in preschool-age very preterm children with working memory impairment. 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 5½ to 6 years, born between 24- and 34-weeks' gestational age, with a global intelligence quotient > 70 and a working memory index < 85. 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. This project's 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. NCT02757794 (registered on 2nd May 2016 at ClinicalTrial.gov).

Sections du résumé

BACKGROUND
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 months) of cognitive training (Cogmed) on visuospatial processing in preschool-age very preterm children with working memory impairment.
METHODS
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 5½ to 6 years, born between 24- and 34-weeks' gestational age, with a global intelligence quotient > 70 and a working memory index < 85. 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.
DISCUSSION
This project's 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.
TRIAL REGISTRATION
NCT02757794 (registered on 2nd May 2016 at ClinicalTrial.gov).

Identifiants

pubmed: 34517869
doi: 10.1186/s12887-021-02867-x
pii: 10.1186/s12887-021-02867-x
pmc: PMC8436542
doi:

Banques de données

ClinicalTrials.gov
['NCT02757794']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

402

Investigateurs

Meriem Zahed (M)
Patricia Garcia (P)
Tristan Desiles (T)
Ludovic Zahed (L)
Mélodie Pache (M)
Gwenaëlle Menard (G)
Nathalie Bednarek Weirauch (N)
Karine Voirin (K)
Virginie Verriere (V)
Gilles Cambonie (G)
Claire Lerat (C)
Maythé Poujol (M)
Olivier Claris (O)
Sophie Rubio Gurung (S)
Eliane Basson (E)
Melanie Rodriguez (M)
Anne Rannaud (A)
Johanna Boulant (J)
Thierry Debillon (T)
Isabelle Pin (I)
Karine Guichardet (K)
Caroline Tournegros (C)
Laurence Foix L'Helias (L)
Delphine Mitanchez (D)
Jennifer Sommer (J)
Hélène Ruys Masson (H)
Michele Granier (M)
Marylène Riou (M)
Dalia Mignot (D)
Bernard Guillois (B)
Valérie Dorriere Datin (V)
Mireille Denaveaut Boulay (M)
Delphine Rots (D)
Jean-Michel Hascot (JM)
Hélène Deforge (H)
Sabine Guignon (S)
Pierre Kuhn (P)
Anne de Saint Martin (A)
Claire Zores Koenig (C)
Hélène Musmeaux (H)
Lucille Schneider (L)
Carole Ramousset (C)
Coralie Mangin (C)
Bénédicte Lecomte (B)
Angélique Pannetier (A)
Emmanuelle Rochette (E)
Nelly Goudon-Dubois (N)
Julie Oertel (J)
Sandrine La Planeta (S)
Stéphane Marret (S)
Marie Lemarchand (M)
Nathalie Mestre (N)
Hugues Patural (H)
Sophie Flori (S)
Jean-Christophe Roze (JC)
Charlotte Coudronniere (C)
Hamida Martin (H)
Alix Laurent (A)
Elie Saliba (E)
Patrick Zander (P)
Eva Aoustin (E)
Catherine Arnaud (C)
Emeline Dubois (E)
Stephanie Iannuzzi (S)
Carine Duffaut (C)
Isabelle Souksi Medioni (I)
Magali Rebattel (M)
Elodie Falque (E)
Nathalie Rumeau (N)
Valérie Benhammou (V)
Laetitia Marchand-Martin (L)
Samira Medjahed (S)

Informations de copyright

© 2021. The Author(s).

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Auteurs

Catherine Gire (C)

Department of Neonatology, North Hospital, APHM University Hospital, Marseille, France.
CEReSS - Health Service Research and Quality of Life Center, Faculty of Medicine, Aix-Marseille University, 27 Bd Jean Moulin, 13385, Marseille, cedex 05, France.

Any Beltran Anzola (A)

Department of Neonatology, North Hospital, APHM University Hospital, Marseille, France. any-alejandra.beltran-anzola@univ-amu.fr.
CEReSS - Health Service Research and Quality of Life Center, Faculty of Medicine, Aix-Marseille University, 27 Bd Jean Moulin, 13385, Marseille, cedex 05, France. any-alejandra.beltran-anzola@univ-amu.fr.

Monique Kaminski (M)

University of Paris, CRESS, Obstetrical Perinatal and Pediatric Epidemiology Research Team, EPOPé, INSERM, INRAE, F-75004, Paris, France.

Karine Baumstarck (K)

CEReSS - Health Service Research and Quality of Life Center, Faculty of Medicine, Aix-Marseille University, 27 Bd Jean Moulin, 13385, Marseille, cedex 05, France.

Pierre-Yves Ancel (PY)

Obstetrical, Perinatal, and Pediatric Epidemiology Team, Center of Research in Epidemiology and Statistics (U1153), Paris University, INSERM, Paris, France.
Clinical Research Unit, Center for Clinical Investigation P1419, CHU Cochin Broca Hôtel-Dieu, Paris, France.

Julie Berbis (J)

CEReSS - Health Service Research and Quality of Life Center, Faculty of Medicine, Aix-Marseille University, 27 Bd Jean Moulin, 13385, Marseille, cedex 05, France.

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