{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T07:51:22Z","timestamp":1791532282418,"version":"4.3.4"},"reference-count":41,"publisher":"American Medical Association (AMA)","issue":"4","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Pediatr"],"published-print":{"date-parts":[[2026,4,1]]},"abstract":"<jats:sec>\n                    <jats:title>Importance<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate whether prophylactic intravenous acetaminophen started within 12 hours of birth increases survival without neonatal severe morbidities at 36 weeks\u2019 postmenstrual age.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design, Setting, and Participants<\/jats:title>\n                    <jats:p>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\u2019 gestation, after the phase 2 study identified the optimal dose of acetaminophen) and April 2024. Data analysis was conducted from January to June 2025.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>In the acetaminophen group, patients born at 27 to 28 weeks\u2019 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\u2019 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>The primary outcome was survival without neonatal morbidity evaluated at 36 weeks\u2019 postmenstrual age. The secondary exploratory outcome was ductus arteriosus closure, assessed by echocardiography on day 7.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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\u2019 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, \u22124.0 to 9.3] percentage points; relative risk [RR], 1.04 [95% CI, 0.94 to 1.16]). The ductus arteriosus was considered closed on day 7 in 264 of 371 infants (71.2%) assigned to acetaminophen and 191 of 366 infants (52.2%) assigned to placebo (ARD, 19.0 [95% CI, 12.0 to 25.7] percentage points; RR, 1.36 [95% CI, 1.21 to 1.53]). In the safety analysis, adverse events were not different except for a higher cholestasis rate in the acetaminophen group (25 of 392 infants [6.4%]) vs the placebo group (10 of 386 infants [2.6%]) (ARD, 3.8 [95% CI, 0.9 to 6.9]) percentage points.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions and Relevance<\/jats:title>\n                    <jats:p>This study found that prophylactic acetaminophen treatment for patent ductus arteriosus did not increase survival without neonatal morbidities.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT04459117\">NCT04459117<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1001\/jamapediatrics.2025.6150","type":"journal-article","created":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T16:30:32Z","timestamp":1771259432000},"page":"374","source":"Crossref","is-referenced-by-count":10,"title":["Prophylactic Treatment of Patent Ductus Arteriosus With Acetaminophen"],"prefix":"10.1001","volume":"180","author":[{"given":"Jean-Christophe","family":"Roz\u00e9","sequence":"first","affiliation":[{"name":"Department of Neonatal Medicine, Nantes University Hospital, Inserm, Centre d\u2019Investigation Clinique 1413, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Cambonie","sequence":"additional","affiliation":[{"name":"Department of Neonatal Medicine, Montpellier University Hospital, Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cyril","family":"Flamant","sequence":"additional","affiliation":[{"name":"Department of Neonatal Medicine, Nantes University Hospital, Inserm, Centre d\u2019Investigation Clinique 1413, Nantes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juliana","family":"Patka\u00ef","sequence":"additional","affiliation":[{"name":"Department of Neonatal Medicine, Cochin Port-Royal Hospital, F\u00e9d\u00e9ration Hospitalo-Universitaire PREMA, Assistance Publique\u2013H\u00f4pitaux de Paris Centre, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias","family":"M\u00fchlbacher","sequence":"additional","affiliation":[{"name":"Newborn Research, Department of Neonatology, University Hospital and University of Z\u00fcrich, Z\u00fcrich, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Geraldine","family":"Gascoin","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care, University Hospital, Toulouse, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aline","family":"Rideau Batista Novais","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Robert Debr\u00e9 Hospital, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manon","family":"Tauzin","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care Unit, Centre Hospitalier Intercommunal de Cr\u00e9teil, Cr\u00e9teil, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Le Duc","sequence":"additional","affiliation":[{"name":"Department of Neonatology, Lille University Hospital, Lille, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alain","family":"Beuch\u00e9e","sequence":"additional","affiliation":[{"name":"Neonatology, University of Rennes, CHU Rennes, Inserm, LTSI-UMR 1099, Rennes, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sebastien","family":"Joye","sequence":"additional","affiliation":[{"name":"Department of Mother-Woman-Child, Clinic of Neonatology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evgeniya","family":"Babacheva","sequence":"additional","affiliation":[{"name":"Second Department of Neonatology and Neonatal Intensive Care Unit, General Hospital of Papageorgiou, Aristotle University of Thessaloniki, Thessaloniki, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antoine","family":"Bouissou","sequence":"additional","affiliation":[{"name":"Department of Neonatology, CHU Tours, 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