Department of Paediatrics, Faculty of Clinical Sciences, Nigeria /Jos University Teaching Hospital, Jos, Nigeria.
Department of Community Health, Faculty of Clinical Sciences, College of Health Sciences, University of Jos, Nigeria /Jos University Teaching Hospital, Jos, Nigeria.
Niger J Clin Pract. 2021 May;24(5):762-769. doi: 10.4103/njcp.njcp_535_20.
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.
To demonstrate non-inferiority of methylated spirit to chlorhexidine (CHX) gel for prevention of omphalitis, NNS and mortality at day 28.
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.
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.
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.
脐炎是新生儿败血症（NNS）和死亡的重要原因。脐炎相关新生儿死亡的风险定量估计约为 10%-19%。局部应用防腐剂已被证明可以降低这种风险负担，但尚未得到充分研究。
证明 96%的甲醇与洗必泰（CHX）凝胶在预防脐炎、NNS 和 28 天死亡率方面无差异。
这是一项在 2017 年 7 月至 2018 年 5 月期间进行的、针对 161 对母婴和 162 对母婴的随机、非劣效性试验，分别使用甲醇和 CHX 凝胶进行试验。使用 SPSS 版本 23.0 进行数据分析，以检查脐炎、脐带分离时间、NNS 和死亡率的发生率。相对风险和 95%置信区间分别用作点估计和区间估计，设定 10%的非劣效性边界，而 P 值<0.05 则具有统计学意义。
新生儿的中位年龄为 18 小时；（IQR：8-24）小时，CHX 凝胶组脐炎风险比甲醇组高 2%（RR=1.020；95%CI：0.988-1.053；P=0.053）。脐带分离的中位数时间分别为甲醇组 7.0 天（IQR：2-17）和 CHX 凝胶组 7.0 天（IQR：2-18）（平均差：-0.2145；95%CI=-0.9085-0.4759；P=0.544）。与使用 CHX 凝胶相比，使用甲醇治疗的新生儿 NNS 和死亡率风险没有差异（RR：1.0；95%CI=0.984-1.017；P=1.000）和（RR：1.0；95%CI=0.994-1.018；P=0.986）。
没有证据表明 96%的甲醇在预防新生儿脐炎方面不如 4%的 CHX 凝胶，因此，在无法获得 CHX 凝胶的情况下，它可能是一种安全有效的替代方法。
