Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial
Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial
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DOI：
10.1016/s0140-6736(11)61877-1
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发表时间：
2012-03-17
期刊：
影响因子：
168.9
通讯作者：
Bhutta, Zulfiqar A.
中科院分区：
文献类型：
--
作者：
Soofi, Sajid;Cousens, Simon;Bhutta, Zulfiqar A.
脐带感染是家庭分娩常见的低资源环境中新生儿败血症和死亡的危险因素。我们的目的是评估脐带清洗4%洗必泰（CHX）的解决方案，有或没有用消毒肥皂洗手，对omnitrile和新生儿mortality.Methods的发病率的影响，我们做了两个两个因素，集群随机试验在达杜，信德省，巴基斯坦的农村地区。集群被定义为一个功能性的传统助产士（TBA）所覆盖的人口，并随机分配到四个组（组A至D）与计算机生成的随机数序列。实施和数据收集团队对分配情况不知情。由接受分娩包的参与TBA分娩的活产婴儿有资格入组研究。一种干预措施包括分娩包，其中含有4%的CHX溶液，由传统助产士在出生时涂抹在脐带上，由家庭成员每天涂抹一次，最长沿着14天，同时提供肥皂和促进洗手的教育信息。一种干预措施是只使用CHX溶液，另一种干预措施是只洗手。在对照组中推广标准干脐带护理。主要结局为新生儿脐膨出发生率和新生儿死亡率。该试验在ClinicalTrials.gov注册，编号NCT 00682006。在9741名由参与的传统助产士接生的新生儿中，因子分析表明CHX应用可降低子宫内膜炎的风险（风险比[RR]=0.58，95% CI 0.41-0.82; p=0.002），但没有证据表明洗手的影响（RR=0.83，0.61-1.13; p=0.24）。我们记录了接受CHX清洁的新生儿的新生儿死亡率降低的强有力证据（RR=0.62，95% CI 0.45-0.85; p=0.003），但没有证据表明促进洗手对新生儿死亡率的影响（RR=1.08，0.79-1.48; p=0.62）。我们没有记录到严重的不良事件。解释应用4%CHX的脐带是有效的，在巴基斯坦农村地区，降低脐动脉瘤和新生儿死亡率的风险。在分娩包中提供CHX可能是预防高死亡率环境中新生儿死亡的有用策略。
Background Umbilical cord infection (omphalitis) is a risk factor for neonatal sepsis and mortality in low-resource settings where home deliveries are common. We aimed to assess the effect of umbilical-cord cleansing with 4% chlorhexidine (CHX) solution, with or without handwashing with antiseptic soap, on the incidence of omphalitis and neonatal mortality.Methods We did a two-by-two factorial, cluster-randomised trial in Dadu, a rural area of Sindh province, Pakistan. Clusters were defined as the population covered by a functional traditional birth attendant (TBA), and were randomly allocated to one of four groups (groups A to D) with a computer-generated random number sequence. Implementation and data collection teams were masked to allocation. Liveborn infants delivered by participating TBAs who received birth kits were eligible for enrolment in the study. One intervention comprised birth kits containing 4% CHX solution for application to the cord at birth by TBAs and once daily by family members for up to 14 days along with soap and educational messages promoting hand washing. One intervention was CHX solution only and another was handwashing only. Standard dry cord care was promoted in the control group. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. The trial is registered with ClinicalTrials.gov, number NCT00682006.Findings 187 clusters were randomly allocated to one of the four study groups. Of 9741 newborn babies delivered by participating TBAs, factorial analysis indicated a reduction in risk of omphalitis with CHX application (risk ratio [RR]=0.58, 95% CI 0.41-0.82; p=0.002) but no evidence of an effect of handwashing (RR=0.83, 0.61-1.13; p=0.24). We recorded strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0.62, 95 % CI 0.45-0.85; p=0.003) but no evidence of an effect of handwashing promotion on neonatal mortality (RR=1.08, 0.79-1.48; p=0.62). We recorded no serious adverse events.Interpretation Application of 4% CHX to the umbilical cord was effective in reducing the risk of omphalitis and neonatal mortality in rural Pakistan. Provision of CHX in birth kits might be a useful strategy for the prevention of neonatal mortality in high-mortality settings.