RESUMO
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: â0.2145; 95% CI = â0.9085-0.4759; 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.