{"id":9525,"date":"2026-08-14T15:18:00","date_gmt":"2026-08-14T13:18:10","guid":{"rendered":"https:\/\/fhu-premimpact.org\/?page_id=9525"},"modified":"2026-09-10T11:00:46","modified_gmt":"2026-09-10T09:00:46","slug":"dexpre","status":"publish","type":"page","link":"https:\/\/fhu-premimpact.org\/en\/recherche\/les-projets-en-cours\/dexpre\/","title":{"rendered":"DEXPRE"},"content":{"rendered":"\n
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Efficacit\u00e9 de la s\u00e9dation par dexm\u00e9d\u00e9tomidine versus midzolam sur la dur\u00e9e d’extubation chez les nou<\/strong>veau-n\u00e9s pr\u00e9matur\u00e9s ventil\u00e9s m\u00e9caniquement : essai randomis\u00e9 contr\u00f4l\u00e9 multicentrique<\/p>\n<\/div>\n\n\n\n

\n

Investigateur principal : Dr Cl\u00e9ment CHOLLAT,<\/strong> D\u00e9partement de p\u00e9diatrie n\u00e9onatale, H\u00f4pital Trousseau, AP-HP, Paris

Responsables scientifiques : Pr St\u00e9phane MARRET<\/strong>, H\u00f4pital Charles-Nicolle, CHU Rouen

Promoteur : AP-HP
Source de Financement : PHRC National 2023 (Minist\u00e8re de la Sant\u00e9)<\/p>\n<\/div>\n<\/div>\n\n\n\n

Justification scientifique :<\/h2>\n\n\n\n

Les nouveau-n\u00e9s grands pr\u00e9matur\u00e9s ( < 32 semaines d\u2019am\u00e9norrh\u00e9e) ont le plu souvent besoin d’une ventilation m\u00e9canique invasive pendant l’hospitalisation. Les strat\u00e9giesde protection du poumon immature incluent des dur\u00e9es de ventilation invasive plus courtes avec une utilisation plus pr\u00e9coce de la ventilation non invasive. Les protocoles de s\u00e9dation-analg\u00e9sie pendant la ventilation m\u00e9canique invasive doivent donc \u00eatre adapt\u00e9s \u00e0 ces nouvelles pratiques, pour permettre notamment une extubation rapide, et donc minimiser la d\u00e9pression respiratoire due \u00e0 la s\u00e9dation. La dexm\u00e9d\u00e9tomidine<\/strong> pr\u00e9sente des propri\u00e9t\u00e9s \u00e0 la fois s\u00e9dative et analg\u00e9sique. Il entraine une s\u00e9dation l\u00e9g\u00e8re tout en maintenant une ventilation spontan\u00e9e.De plus, ses propri\u00e9t\u00e9s analg\u00e9siques peuvent permettre une \u00e9pargne morphinique, pouvant ainsi r\u00e9duire les \u00e9checs d’extubation et le syndrome de sevrage. Par ailleurs, la neurotoxixit\u00e9 potentielle des agents anesth\u00e9siques sur le cerveau en d\u00e9veloppement est d\u00e9battue. Les donn\u00e9es actuelles sur la dexm\u00e9d\u00e9tomidine sont rassurantes.<\/p>\n\n\n\n

Objectif principal :<\/h2>\n\n\n\n

Comparer l’efficacit\u00e9 de la s\u00e9dation par la dexm\u00e9d\u00e9tomidine par rapport \u00e0 la s\u00e9dation par le midazolam chez le nouveau-n\u00e9 grand pr\u00e9matur\u00e9.<\/p>\n\n\n\n

Objectifs secondaires :<\/h2>\n\n\n\n
    \n
  • Utilisation d’agents anesth\u00e9siques adjuvants, y compris les opio\u00efdes entre le d\u00e9but du m\u00e9dicament exp\u00e9rimental et l\u2019extubation;<\/li>\n\n\n\n
  • Qualit\u00e9 de la s\u00e9dation;<\/li>\n<\/ul>\n\n\n\n
      \n
    • \u00c9chec de l’extubation dans les 24 heures suivant l’extubation;<\/li>\n<\/ul>\n\n\n\n
        \n
      • Syndrome de sevrage ( score de Finnegan > 8);<\/li>\n<\/ul>\n\n\n\n
          \n
        • Effet ind\u00e9sirables h\u00e9modynamiques et respiratoires entre le d\u00e9but de la s\u00e9dation et 84 heures apr\u00e8s l’arr\u00eat du traitement;<\/li>\n<\/ul>\n\n\n\n
            \n
          • Morbi-mortalit\u00e9 \u00e0 l’h\u00f4pital<\/li>\n<\/ul>\n\n\n\n

            Design de l\u2019essai :<\/h2>\n\n\n\n

            \u00c9tude multicentrique, randomis\u00e9 contr\u00f4l\u00e9 en double-aveugle, contr\u00f4l\u00e9e.<\/p>\n\n\n\n

            Population concern\u00e9e :<\/h2>\n\n\n\n

            Nouveau-n\u00e9 grand pr\u00e9matur\u00e9 (\u00e2ge gestationnel \u00e0 la naissance < 32 semaine d\u2019am\u00e9norrh\u00e9e) avec un \u00e2ge gestationnel corrig\u00e9 \u00e0 l’inclusion < 45 semaine d\u2019am\u00e9norrh\u00e9e.<\/p>\n\n\n\n

            M\u00e9dicament exp\u00e9rimental :<\/h2>\n\n\n\n

            dexm\u00e9d\u00e9tomidine<\/strong><\/span> : administration intraveineuse continue avec :
            – une dose de charge de 0, 05 \u00b5g\/kg sur 30 minutes
            – suivie d’une dose d’entretien (de 0,05 \u00e0 0,2 \u00b5g\/kg\/heure)
            Midazolam<\/strong> : administration intraveineuse continue avec :
            – une dose de charge de 10 \u00b5g\/kg sur 30 minutes
            – suivie d’une dose d’entretien (de 10 \u00e0 40 \u00b5g\/kg\/heure)<\/p>\n\n\n\n

            D\u00e9roulement de l’\u00e9tude<\/h2>\n\n\n\n
              \n
            • Visite d’inclusion <\/li>\n\n\n\n
            • Randomisation<\/li>\n\n\n\n
            • Visite de suivi ( recueil des donn\u00e9es pendant l\u2019hospitalisation)<\/li>\n\n\n\n
            • A 2ans d’\u00e2ge corrig\u00e9 : paralysie c\u00e9r\u00e9brale selon le syst\u00e8me de classification de la fonction motrice globale(GMFCS), \u00e2ge d’acquisition de la marche, questionnaire Ages 1 stages (ASQ)<\/em><\/li>\n<\/ul>\n\n\n\n

              Nombre de sujets n\u00e9cessaires :<\/h2>\n\n\n\n

              380 patients inclus pour randomiser 292 patients.<\/p>\n\n\n\n

              Nombre de centres :<\/h2>\n\n\n\n

              12 centres en France.<\/p>\n\n\n\n

              Calendrier de l’\u00e9tude :<\/h2>\n\n\n\n
                \n
              • Dur\u00e9e des inclusions : 24 mois.<\/li>\n\n\n\n
              • Dur\u00e9e de participation (traitement + suivi) : maximum 27 mois<\/li>\n\n\n\n
              • Dur\u00e9e totale de l\u2019essai : 51mois.<\/li>\n<\/ul>\n\n\n\n

                \u00c9tat d’avancement :<\/h2>\n\n\n\n

                Les services de m\u00e9decines et r\u00e9animation n\u00e9onatales des h\u00f4pitaux Armand Tousseau AP-HP, Robert Debr\u00e9 AP-HP et Cochin Port-Royal AP-HP participent \u00e0 cette \u00e9tude.<\/p>\n\n\n\n

                Les inclusions ont d\u00e9marr\u00e9es (25 patients inclus dont 10 randomis\u00e9s au 10 ao\u00fbt 2026).<\/p>\n\n\n\n

                <\/p>\n\n\n\n

                <\/p>\n\n\n\n

                <\/p>\n","protected":false},"excerpt":{"rendered":"

                Efficacit\u00e9 de la s\u00e9dation par dexm\u00e9d\u00e9tomidine versus midzolam sur la dur\u00e9e d’extubation chez les nouveau-n\u00e9s pr\u00e9matur\u00e9s ventil\u00e9s m\u00e9caniquement : essai randomis\u00e9 contr\u00f4l\u00e9 multicentrique Investigateur principal : Dr Cl\u00e9ment CHOLLAT, D\u00e9partement de p\u00e9diatrie n\u00e9onatale, H\u00f4pital Trousseau, AP-HP, Paris Responsables scientifiques : Pr St\u00e9phane MARRET, H\u00f4pital Charles-Nicolle, CHU Rouen Promoteur : AP-HPSource de Financement : PHRC National 2023 (Minist\u00e8re de […]<\/p>\n","protected":false},"author":87,"featured_media":0,"parent":2462,"menu_order":22,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_editorskit_title_hidden":false,"_editorskit_reading_time":1,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","_uag_custom_page_level_css":"","footnotes":""},"class_list":["post-9525","page","type-page","status-publish","hentry"],"yoast_head":"\nDEXPRE - 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