Does oral azithromycin administered during labour reduce neonatal sepsis and mortality?

Reviewed by Michael Oji, MBBS, MPH, FMCS, FSHEA, NAHAL Consults Nigeria

In a bid to find solutions to neonatal sepsis and mortality, authors tried to answer the question of whether oral azithromycin would decrease the risk of neonatal sepsis and mortality. A multi-center, multi-country randomized, placebo- controlled double blind trial conducted in 10 facilities in Burkina Faso and The Gambia studied the effect of azithromycin administered orally during labour on neonatal sepsis and morality, in addition to antibiotics given as standard of care. Around 12,000 persons in labor were randomized; the incidence of neonatal sepsis or mortality was similar in the azithromycin and placebo groups (2.0% [115/5889] vs 1.9% [110/5894]; risk difference [RD], 0.09 [95% CI, -0.39 to 0.57]), as was the incidence of neonatal mortality (0.8% vs 0.8%; RD, 0.04 [95% CI, -0.27 to 0.35]) and neonatal sepsis (1.3% vs 1.3%; RD, 0.02 [95% CI, -0.38 to 0.43]).They did note that the incidence of non-invasive infections during the immediate 4 weeks post-natal period was reduced for the parents and newborns in the group that received oral azithromycin.

Roca A, Camara B, Bognini JD, Nakakana UN, Somé AM, Beloum N, Rouamba T, Sillah F, Danso M, Jones JC, Graves S, Jagne I, Getanda P, Darboe S, Tahita MC, Ndure E, Franck HS, Edmond SY, Dondeh BL, Nassa WGJ, Garba Z, Bojang A, Njie Y, Bottomley C, Tinto H, D’Alessandro U; PregnAnZI-2 Working Group. Effect of Intrapartum Azithromycin vs Placebo on Neonatal Sepsis and Death: A Randomized Clinical Trial. JAMA. 2023 Mar 7;329(9):716-724. doi: 10.1001/jama.2022.24388. PMID: 36881034; PMCID: PMC9993186.

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