{"id":8932,"date":"2025-12-08T12:20:00","date_gmt":"2025-12-08T11:20:19","guid":{"rendered":"https:\/\/fhu-premimpact.org\/?page_id=8932"},"modified":"2026-06-05T11:17:45","modified_gmt":"2026-06-05T09:17:45","slug":"protocole-tocokids","status":"publish","type":"page","link":"https:\/\/fhu-premimpact.org\/en\/recherche\/les-projets-en-cours\/protocole-tocokids\/","title":{"rendered":"TOCOKIDS"},"content":{"rendered":"\n
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Suivi \u00e0 6 ans des enfants n\u00e9s de m\u00e8res expos\u00e9es \u00e0 la nifedipine ou placebo apr\u00e8s une rupture pr\u00e9matur\u00e9e des membranes entre 22 et 33 semaines d\u2019am\u00e9norrh\u00e9e<\/strong><\/p>\n<\/div>\n\n\n\n

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Investigateur principal\u00a0: Pr Gilles KAYEM,<\/strong> H\u00f4pital Trousseau, AP-HP, Paris

Responsables scientifiques\u00a0: Dre Elsa LORTHE,<\/strong> INSERM U1153, OPPaLE & Anna Cognet, Laboratoire de Psychologie Caen Normandie (LPCN – EA7452)

Promoteur : Assistance Publique \u2013 H\u00f4pitaux de Paris
Source de Financement\u00a0: PHRC National 2022 (Minist\u00e8re de la Sant\u00e9)

Num\u00e9ro clinicaltrials\u00a0: NCT07146451<\/p>\n<\/div>\n<\/div>\n\n\n\n

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

La rupture pr\u00e9matur\u00e9e des membranes avant terme (RPMAT) complique 3 % des grossesses et repr\u00e9sente un tiers des naissances pr\u00e9matur\u00e9es. Il s\u2019agit d\u2019une cause majeure de mortalit\u00e9 et de morbidit\u00e9 n\u00e9onatales et augmente le risque de morbidit\u00e9 infectieuse maternelle. En cas de RPMAT pr\u00e9coce, entre 22 et 33 semaines d\u2019am\u00e9norrh\u00e9e (SA), une prise en charge expectative est recommand\u00e9e en l’absence de travail, de chorioamnionite ou de d\u00e9tresse foetale.
Les recommandations internationales pr\u00e9conisent \u00e9galement d\u2019administrer une corticoth\u00e9rapie et une antibioth\u00e9rapie ant\u00e9natales. Cependant, il n’existe aucune recommandation concernant l’administration de tocolyse dans le cadre d’une RPMAT. En th\u00e9orie, la r\u00e9duction de la contractilit\u00e9 ut\u00e9rine pourrait retarder l’accouchement et donc r\u00e9duire les risques de pr\u00e9maturit\u00e9 et de cons\u00e9quences n\u00e9onatales d\u00e9l\u00e9t\u00e8res. De m\u00eame, la prolongation de la grossesse pourrait permettre d\u2019administrer une cure compl\u00e8te de cortico\u00efdes, associ\u00e9e \u00e0 une r\u00e9duction de moiti\u00e9 des risques de morbi-mortalit\u00e9 n\u00e9onatale.
Toutefois, la tocolyse pourrait prolonger l’exposition du foetus \u00e0 l’inflammation et \u00eatre associ\u00e9e \u00e0 un risque plus \u00e9lev\u00e9 d’infection materno-foetale, potentiellement associ\u00e9e \u00e0 la mortalit\u00e9 p\u00e9rinatale ou \u00e0 des s\u00e9quelles \u00e0 long terme, y compris la paralysie c\u00e9r\u00e9brale.
Nous avons initi\u00e9 l\u2019essai randomis\u00e9 TOCOPROM pour \u00e9valuer si l\u2019administration d\u2019une tocolyse pendant 48h suite \u00e0 une RPMAT entre 22 et 33 SA permet de r\u00e9duire la morti-morbidit\u00e9 p\u00e9rinatale. Cependant, les r\u00e9sultats \u00e0 court et \u00e0 long terme doivent \u00eatre pris en compte pour d\u00e9finir la strat\u00e9gie optimale de traitement. Il n’existe actuellement aucune donn\u00e9e permettant d’\u00e9valuer l’impact d’un traitement court de nif\u00e9dipine par rapport \u00e0 un placebo sur les r\u00e9sultats neurod\u00e9veloppementaux chez les enfants d’\u00e2ge scolaire n\u00e9s apr\u00e8s une RPMAT. Par cons\u00e9quent, le suivi des enfants n\u00e9s de m\u00e8res ayant particip\u00e9 \u00e0 l’essai TOCOPROM, par le biais d’une nouvelle \u00e9tude, la cohorte TOCOKIDS, est une occasion unique de faire progresser les connaissances scientifiques et d’adapter les pratiques cliniques en France et dans le monde.<\/p>\n\n\n\n

Objectif principal :<\/h2>\n\n\n\n

\u00c9valuer le d\u00e9veloppement neurologique \u00e0 l’\u00e2ge de 6 ans des enfants n\u00e9s de femmes ayant eu une RPMAT entre 22 et 33 semaines d\u2019am\u00e9norrh\u00e9e, apr\u00e8s exposition ant\u00e9natale \u00e0 la nif\u00e9dipine vs placebo.<\/p>\n\n\n\n

Objectifs secondaires :<\/h2>\n\n\n\n

\u00c9valuer l’impact de l’exposition ant\u00e9natale \u00e0 la nif\u00e9dipine vs placebo apr\u00e8s une RPMAT sur d’autres dimensions de la sant\u00e9 et du fonctionnement des enfants et des parents.
\u00c9valuer la faisabilit\u00e9 d’une \u00e9valuation psychologique en ligne dans une population d’enfants d’\u00e2ge scolaire, y compris de nombreux enfants pr\u00e9matur\u00e9s.
\u00c9valuer le d\u00e9veloppement neurologique des enfants en fonction d’autres complications ant\u00e9natales, telles que l’infection intra-ut\u00e9rine.<\/p>\n\n\n\n

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

Tous les enfants n\u00e9s de m\u00e8res ayant particip\u00e9 \u00e0 l’essai TOCOPROM pourront \u00eatre inclus dans la cohorte TOCOKIDS.<\/p>\n\n\n\n

Nombre de sujets s\u00e9lectionn\u00e9s :<\/h2>\n\n\n\n

La taille de l’\u00e9chantillon sera d\u00e9termin\u00e9e par le nombre de participants \u00e0 l’essai original (n=850 femmes enceintes). En mars 2024, nous avons enregistr\u00e9 5,6 % de mort-n\u00e9s, d’interruptions de grossesse ou de d\u00e9c\u00e8s n\u00e9onataux. Cela correspondrait \u00e0 un total de 45 \u00e0 50 enfants non \u00e9ligibles pour le suivi de 6 ans. Sur ces 800 enfants, nous attendons un taux de participation de 60%. Nous pr\u00e9voyons donc d’inclure 480 enfants dans la cohorte TOCOKIDS.<\/p>\n\n\n\n

Nombre de centres :<\/h2>\n\n\n\n

1 (toutes les proc\u00e9dures de l’\u00e9tude seront effectu\u00e9es de mani\u00e8re centralis\u00e9e par l’\u00e9quipe de recherche).<\/p>\n\n\n\n

Calendrier de l’\u00e9tude :<\/h2>\n\n\n\n

Dur\u00e9e de participation : 30 minutes (\u00e9valuation psychologique) + environ 20 \u00e0 30 minutes pour remplir le questionnaire en ligne (\u00e0 l’\u00e2ge de 6 ans, maximum 6 ans et 6 mois).<\/p>\n\n\n\n

Dur\u00e9e totale de l\u2019essai : 84 mois.<\/p>\n\n\n\n

D\u00e9roulement pratique<\/h2>\n\n\n\n

L’\u00e9valuation \u00e0 l’\u00e2ge de 6 ans consistera en :<\/p>\n\n\n\n

    \n
  • un auto-questionnaire parental compl\u00e9t\u00e9 en ligne ou sur papier<\/li>\n\n\n\n
  • Des donn\u00e9es recueillies dans le carnet de sant\u00e9, notamment lors de la consultation \u00e0 6 ans<\/li>\n\n\n\n
  • Une courte \u00e9valuation psychologique (30 minutes), r\u00e9alis\u00e9e \u00e0 distance par un psychologue \u00e0 l’aide d’une plateforme de visioconf\u00e9rence.<\/li>\n<\/ul>\n\n\n\n

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

    La 1\u00e8re<\/sup> inclusion a eut lieu le 28\/10\/2025. Au 31 mars, 21 patients sont inclus.<\/p>\n\n\n\n

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

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

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

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

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