{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T03:56:04Z","timestamp":1789703764187,"version":"4.0.1"},"reference-count":22,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2023,3,7]]},"abstract":"\n Importance<\/jats:title>\n Neonatal sepsis is a leading cause of neonatal mortality. New interventions are needed to decrease neonatal sepsis and mortality in regions with highest burden.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy of intrapartum azithromycin to reduce neonatal sepsis or mortality, as well as neonatal and maternal infections.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This double-blind, placebo-controlled, randomized clinical trial enrolled and followed up birthing parents and their infants at 10 health facilities in The Gambia and Burkina Faso, West Africa, between October 2017 and May 2021.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were assigned at random to receive oral azithromycin (2 g) or placebo (ratio 1:1) during labor.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was a composite of neonatal sepsis or mortality, with the former defined based on microbiologic or clinical criteria. Secondary outcomes were neonatal infections (skin, umbilical, eye and ear infections), malaria, and fever; postpartum infections (puerperal sepsis, mastitis), fever, and malaria; and use of antibiotics during 4-week follow-up.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n The trial randomized 11\u202f983 persons in labor (median age, 29.9 years). Overall, 225 newborns (1.9% of 11\u202f783 live births) met the primary end point. The incidence of neonatal mortality or sepsis was similar in the azithromycin and placebo groups (2.0% [115\/5889] vs 1.9% [110\/5894]; risk difference [RD], 0.09 [95% CI, \u22120.39 to 0.57]), as was the incidence of neonatal mortality (0.8% vs 0.8%; RD, 0.04 [95% CI, \u22120.27 to 0.35]) and neonatal sepsis (1.3% vs 1.3%; RD, 0.02 [95% CI, \u22120.38 to 0.43]). Newborns in the azithromycin group compared with the placebo group had lower incidence of skin infections (0.8% vs 1.7%; RD, \u22120.90 [95% CI, \u22121.30 to \u22120.49]) and need for antibiotics (6.2% vs 7.8%; RD, \u22121.58 [95% CI, \u22122.49 to \u22120.67]). Postpartum parents in the azithromycin group had lower incidence of mastitis (0.3% vs 0.5%; RD, \u22120.24 [95% CI, \u22120.47 to \u22120.01]) and puerperal fever (0.1% vs 0.3%; RD, \u22120.19 [95% CI, \u22120.36 to \u22120.01]).<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Azithromycin administered orally during labor did not reduce neonatal sepsis or mortality. These results do not support routine introduction of oral intrapartum azithromycin for this purpose.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT03199547<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2022.24388","type":"journal-article","created":{"date-parts":[[2023,3,7]],"date-time":"2023-03-07T11:31:45Z","timestamp":1678188705000},"page":"716","source":"Crossref","is-referenced-by-count":58,"title":["Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death"],"prefix":"10.1001","volume":"329","author":[{"given":"Anna","family":"Roca","sequence":"first","affiliation":[{"name":"MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, The Gambia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bully","family":"Camara","sequence":"additional","affiliation":[{"name":"MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Fajara, 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