| Title: |
Prophylactic Treatment of Patent Ductus Arteriosus With Acetaminophen |
| Authors: |
Rozé, Jean-Christophe; Cambonie, Gilles; Flamant, Cyril; Patkaï, Juliana; Mühlbacher, Tobias; Gascoin, Geraldine; Rideau Batista Novais, Aline; Tauzin, Manon; Le Duc, Kevin; Beuchée, Alain; Joye, Sebastien; Babacheva, Evgeniya; Bouissou, Antoine; Ligi, Isabelle; Tammela, Outi; Plourde, Marion; Dempsey, Eugene; Tosello, Barthelemy; Nguyen, Kim; Vincent, Marine; Andresson, Pille; Binder, Christoph; Kruse, Charlotte; Barcos Munoz, Francisca; Kuhn, Pierre; Proença, Elisa; Bartocci, Marco; Kermorvant-Duchemin, Elsa; Nellis, Georgi; Lumia, Mirka; Giapros, Vasileios; Rigo, Vincent; Sankilampi, Ulla; Mendes da Graça, André; Rønnestad, Arild; Soukka, Hanna; Mondì, Vito; Aikio, Outi; Torre-Monmany, Nuria; Rüegger, Christoph; Baud, Olivier; Zeitlin, Jennifer; Morgan, Andrei Scott; Baruteau, Alban-Elouen; Ancel, Pierre-Yves; Carbajal, Ricardo; Bouazza, Naim; Diallo, Alpha; Levoyer, Lea; Kemper, Ruth; Hallman, Mikko; Alberti, Corinne; Ursino, Moreno; Jarreau, Pierre-Henri; Vanhecke, Aure; Desplebin, Victorine; Bouafia, Naouel; Torchin, Heloise; Proenca, Elisa; Mazille, Nadia; Reynold de Seresin, Magali; Simon, Laure; Callies, Arnaud; Fintzou, Maria; Malakozi, Marina; Moreau, Marie; Murray, Anne; Ovaskainen, Katja; Palmu, Sauli; Eger, Siw Helen; Baraton, Louis; Kirschenhofer, Susanne; Mellul, Kelly; Sorin, Gaelle; Treluyer, Ludovic; Healy, David; Ilmoja, Mari Liis; Rallis, Dimitrios; Yager, Helene; Zana-Taieb, Elodie; Carneiro, Laure; Cipierre, Cecile; Corredera, Araceli; Dassieu, Gilles; Debbiche, Rim; Decobert, Fabrice; Evaggelidis, Leif; Garbi, Aurelie; Hallik, Maarja; Jourdes, Emilie; Langlet Muteau, Claire; Leboucher, Bertrand; Panaviene, Jurate; Apprioual, Geraldine; Auzet, Clemence; Bellanger, Claire; Benard, Melinda; Biran, Valerie; Boubred, Farid; Butin, Marine; David, Melissa; Detristan, Marie Amelie; Dicky, Odile; Dillenseger, Laurence; Dorronsoro, Izaskun; Durrmeyer, Xavier; Laborie, Sophie; Lallemant, Carine; Lefevre, Noemie; Lescure, Sandra; Montjaux, Nathalie; Ragouilliaux, Corinne; Sarda, Marta; Schieber, Helene; Stensvold, Hans Jorgen; Strommen, Kenneth; Virtuoso, Joao; Zayat, Noura; Abbal, Julie; Ahmed, Nahla; Berenguer, Alberto; Chioma, Roberto; Delorme, Sophie; Garnier, Elodie; Gil, Joana; Gouveia, Raquel; Grand Vuillemin, Isabelle; Hovhannisyan, Shushanik; Paoulillo, Piermichele; Passarella, Chiara; Pellot, Anne Sophie; Picone, Simonetta; Podimatas, Nikolaos; Prior, Ana Rita; Rebelo, Monica; Robert de Saint Vincent, Marine; Sainz, Angela; Santos, Edmundo; Suhard, Juliette; Theveniaut, Camille; Ukkonen, Tiina; Yverneau, Mathilde |
| Contributors: |
Physiopathologie des Adaptations Nutritionnelles (PhAN); Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE); Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé; Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ); Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes); CHU Montpellier = Montpellier University Hospital; Centre Hospitalier Régional Universitaire Montpellier (CHRU Montpellier); Fédération Hospitalo-Universitaire Combattre la prématurité (FHU PREMA); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Universität Zürich Zürich = University of Zurich (UZH); Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); Hôpital Robert Debré; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital universitaire Robert Debré Reims (CHU Reims); Centre Hospitalier Intercommunal de Créteil (CHIC); Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; Laboratoire Traitement du Signal et de l'Image (LTSI); Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM); Centre Hospitalier Universitaire Vaudois = Lausanne University Hospital Lausanne (CHUV); Aristotle University of Thessaloniki; Centre Hospitalier Régional Universitaire de Tours (CHRU Tours); Assistance Publique - Hôpitaux de Marseille (APHM); Centre for Research in Epidemiology and Statistics; Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE); University College London UCL (UCL); Centre d'Investigation Clinique 1426 (CIC 1426); Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré Paris; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP); Health data-and model-driven approaches for Knowledge Acquisition (HeKA; Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Inria de Paris; Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Université Paris Cité (UPCité); The TREOCAPA trial is funded by conect4children, which has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 777389. The joint undertaking receives support from the European Union’s Horizon 2020 research and innovation program and the European Federation of Pharmaceutical Industries Associations.; European Project: 777389,H2020-JTI-IMI2-2016-10-two-stage,H2020-JTI-IMI2-2016-10-two-stage,c4c(2018) |
| Source: |
ISSN: 2168-6203. |
| Publisher Information: |
CCSD; American Medical Association - JAMA Network |
| Publication Year: |
2026 |
| Subject Terms: |
[SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics |
| Description: |
International audience ; Importance: Controversies persist about management of the ductus arteriosus by nonsteroidal anti-inflammatory drugs in extremely preterm infants. Acetaminophen (paracetamol) appears to be a promising alternative with possibly fewer adverse effects.Objective: To evaluate whether prophylactic intravenous acetaminophen started within 12 hours of birth increases survival without neonatal severe morbidities at 36 weeks' postmenstrual age.Design, setting, and participants: A double-blind, randomized, placebo-controlled clinical trial was conducted among preterm infants born between 23 weeks 0 days and 28 weeks 6 days of gestation in 43 neonatal intensive care units of 14 European countries between October 2020 (October 2021 for infants born at 23-26 weeks' gestation, after the phase 2 study identified the optimal dose of acetaminophen) and April 2024. Data analysis was conducted from January to June 2025.Intervention: In the acetaminophen group, patients born at 27 to 28 weeks' gestation received a 20-mg/kg loading dose of acetaminophen followed by 7.5 mg/kg every 6 hours for 5 days, and patients born at 23 to 26 weeks' gestation received a 25-mg/kg loading dose of acetaminophen followed by 10 mg/kg every 6 hours for 5 days. In the placebo group, isotonic sodium chloride was administered.Main outcomes and measures: The primary outcome was survival without neonatal morbidity evaluated at 36 weeks' postmenstrual age. The secondary exploratory outcome was ductus arteriosus closure, assessed by echocardiography on day 7.Results: A total of 778 patients (median [IQR] gestational age, 26 [25-27] weeks; 375 [48.2%] female) were included in the study, with 391 in the acetaminophen group and 387 in the placebo group. Survival without severe morbidities at 36 weeks' postmenstrual age occurred in 259 infants (66.2%) in the acetaminophen group and 246 (63.6%) in the placebo group (absolute risk difference [ARD], 2.7 [95% CI, -4.0 to 9.3] percentage points; relative risk [RR], 1.04 [95% CI, 0.94 to 1.16]). ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/41697673; info:eu-repo/grantAgreement//777389/EU/conect4children (COllaborative Network for European Clinical Trials For Children)/c4c; PUBMED: 41697673 |
| DOI: |
10.1001/jamapediatrics.2025.6150 |
| Availability: |
https://hal.inrae.fr/hal-05539868; https://doi.org/10.1001/jamapediatrics.2025.6150 |
| Accession Number: |
edsbas.F3C6E148 |
| Database: |
BASE |