LAUSR

Background: Omphalitis is an important cause of neonatal sepsis (NNS) and mortality. Quantitative estimates of risk of omphalitis-related neonatal death is about 10%–19%. Topical applications of antiseptics have been shown to reduce this risk burden but has not been well investigated. Aim: To demonstrate non-inferiority of methylated spirit to chlorhexidine (CHX) gel for prevention of omphalitis, NNS and mortality at day 28. Methods: This was a randomized, non-inferiority trial of methylated spirit versus CHX gel with 161 and 162 mother–baby pairs, respectively, conducted between July 2017 and May 2018. SPSS version 23.0 was used for data analysis to examine for incidence of omphalitis, time-to-cord separation, NNS and mortality. Relative risk and 95% confidence interval were used as point and interval estimates, respectively, with a non-inferiority margin of 10% set for CHX gel while a P values <0.05 was statistically significant. Results: The median age of newborns was 18 h; (IQR: 8–24) h with the risk of omphalitis being 2% higher with CHX gel compared to methylated spirit (RR = 1.020; 95% CI; 0.988-1.053; P = 0.053). The median times-to-cord separation were 7.0 days (IQR: 2–17) and 7.0 days (IQR: 2–18) for methylated spirit and CHX gel, respectively (mean difference: ‒0.2145; 95% CI = ‒0.9085–0.4759; P = 0.544). There was no difference in the risks of NNS and mortality among those treated with methylated spirit compared to those exposed to CHX gel (RR: 1.0; 95% CI = 0.984–1.017; P = 1.000) and (RR: 1.0; 95% CI = 0.994–1.018; P = 0.986) respectively. Conclusions: There is no evidence that 96% methylated spirit is inferior to 4% CHX gel in preventing neonatal omphalitis; hence, it may be considered a safe and effective alternative where CHX gel is unavailable.