{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T15:57:08Z","timestamp":1781193428930,"version":"3.54.1"},"reference-count":39,"publisher":"American Medical Association (AMA)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n Neonatal sepsis causes substantial mortality. Topical antisepsis for laboring women or neonates may reduce pathogenic colonization and sepsis risk.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the safety and effectiveness of various topical antiseptic regimens to reduce bacterial load in the maternal genital tract and on neonatal skin and assess suitability for future effectiveness trials.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This randomized clinical trial was conducted from March 7, 2022, to March 29, 2023, at Zomba Central Hospital, Malawi, with 28-day follow-up. Participant populations were laboring women and, separately, facility-born neonates (aged &amp;lt;24 hours and with birth weight &amp;gt;1000 g) not born to a mother recruited to the trial. Data were analyzed from May 17 to December 28, 2023.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were individually randomized in an unblinded factorial design to chlorhexidine 1% (1% CHG), chlorhexidine 2% (2% CHG), or octenidine 0.1% with phenoxyethanol 2% (OHP), each applied either once or multiple times (maternal: antiseptic applied every 4 hours during working hours for up to 6 applications; neonatal: antiseptic applied every 24 hours for up to 3 applications), or to standard of care (SOC; application of sterile water for mothers and no cleansing for neonates). Laboratory staff assessing primary outcomes were blinded.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Co\u2013primary outcomes were change in total skin bacterial load (log10 colony-forming units [log10CFU]) from baseline at each follow-up, analyzed separately in the maternal and neonatal populations and adjusted for intervention variables. Secondary outcomes included skin condition score (range, 0-12 for neonates and 0-16 for women; lower scores indicate better condition), serious adverse events (SAEs), and neonatal temperature.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 149 women (mean [SD] age at enrollment, 25.7 [5.9] years) and 147 neonates (mean [SD] age at enrollment, 10.3 [6.3] hours; 82 [56%] male) participated. Mean (SD) infant gestational age was 37.7 (1.5) weeks in the maternal population and 36.7 (3.1) weeks in the neonatal population. Neonates\u2019 mean birth weight was 2729 g (712 g). Among mothers, compared with 1% CHG, bacterial load was higher (worse) with OHP (adjusted log10CFU difference, 1.7; 95% CI, 0.9-2.5) and SOC (3.5; 95% CI, 2.4-4.6); there was no clear log10CFU difference with 2% CHG (\u22120.6; 95% CI, \u22121.4 to 0.2). There was no evidence of difference in effectiveness between multiple vs single application (log10CFU difference, \u22120.4; 95% CI, \u22121.1 to 0.2). In neonates, 1% CHG showed greater effectiveness than SOC (log10CFU difference, 1.3; 95% CI, 0.2-2.4) but no difference vs 2% CHG (\u22120.2; 95% CI, \u22121.1 to 0.7) or OHP (0.7; 95% CI, \u22120.2 to 1.6). Multiple applications showed increasing benefits over time (frequency\u2009\u00d7\u2009time interaction). Skin scores were low (almost all were 0-1 and none \u22653). There were no significant differences in SAE rates between arms and no signal of postantiseptic neonatal hypothermia.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this randomized clinical trial of topical antiseptics applied in laboring women and in neonates, 1% CHG reduced maternal and neonatal bacterial colonization without safety concerns, suggesting it would be the optimal regimen to evaluate in a larger pragmatic trial powered for clinical outcomes.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ISRCTN Registry Identifier:\n ISRCTN78026255<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.15665","type":"journal-article","created":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T15:00:42Z","timestamp":1781190042000},"page":"e2615665","source":"Crossref","is-referenced-by-count":0,"title":["Antiseptic Cleansing to Reduce Vertical Transmission of Pathogens to Neonates"],"prefix":"10.1001","volume":"9","author":[{"given":"Emily","family":"Beales","sequence":"first","affiliation":[{"name":"Centre for Neonatal and Paediatric Infection, Institute for Infection and Immunity, City St George\u2019s, University of London, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michelle N.","family":"Clements","sequence":"additional","affiliation":[{"name":"University College London Innovative Clinical Trials Unit, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas A.","family":"Feasey","sequence":"additional","affiliation":[{"name":"School of Medicine, University of St Andrews, St Andrews, United Kingdom"},{"name":"Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Lissauer","sequence":"additional","affiliation":[{"name":"Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi"},{"name":"Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maranatha","family":"Banda","sequence":"additional","affiliation":[{"name":"Zomba Central Hospital, Zomba, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bertha","family":"Maseko","sequence":"additional","affiliation":[{"name":"Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia A.","family":"Bielicki","sequence":"additional","affiliation":[{"name":"Centre for Neonatal and Paediatric Infection, Institute for Infection and Immunity, City St George\u2019s, University of London, London, United Kingdom"},{"name":"Paediatric Research Centre, University Children\u2019s Hospital, Basel, Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Lissauer","sequence":"additional","affiliation":[{"name":"Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi"},{"name":"Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Liverpool, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aisleen","family":"Bennett","sequence":"additional","affiliation":[{"name":"Department of Paediatric Infectious Diseases, Imperial College Healthcare, NHS Trust, London, United Kingdom"},{"name":"Paediatric Infectious Disease, Department of Infectious Disease, Imperial College, London, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kondwani","family":"Kawaza","sequence":"additional","affiliation":[{"name":"Department of Paediatrics and Child Health, Kamuzu University of Health Sciences, Blantyre, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luis A.","family":"Gadama","sequence":"additional","affiliation":[{"name":"Malawi-Liverpool-Wellcome Programme, Blantyre, Malawi"},{"name":"Obstetrics and Gynaecology Department, Kamuzu University of Health Sciences, Blantyre, Malawi"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. 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