Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial
Effectiveness of 4% chlorhexidine umbilical cord care on neonatal mortality in Southern Province, Zambia (ZamCAT): a cluster-randomised controlled trial
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DOI：
10.1016/s2214-109x(16)30215-7
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发表时间：
2016-11-01
影响因子：
34.3
通讯作者：
Hamer, Davidson H.
中科院分区：
文献类型：
--
作者：
Semrau, Katherine E. A.;Herlihy, Julie;Hamer, Davidson H.
背景：洗必泰脐带冲洗可降低南亚新生儿死亡率高且主要在家中分娩的新生儿死亡率。没有关于新生儿死亡率较低或大多在医院分娩的撒哈拉以南非洲人口的数据。我们比较了洗必泰与干脐带护理对新生儿死亡率在Zambia.Methods的影响，我们进行了一个集群随机对照试验，在南部省，赞比亚，90卫生设施为基础的集群。我们招募了处于妊娠中期或晚期的女性，年龄至少为15岁，并将在产后28天留在集水区进行随访。根据分组分配，新生儿接受清洁干燥脐带护理（对照）或每天一次局部应用10 mL 4%氯己定溶液，直至脐带脱落后3天（干预）。我们采用分层、限制性随机化方法将群组分为城市组或两个农村组（距离< 40 km or >转诊机构= 40 km），并随机分配群组（1：1）进行干预（n=45）或对照治疗（n=45）。研究中心、受试者和现场监查员了解他们的研究任务。主要结局是产后28天内的全因新生儿死亡率和出生后24小时内存活的婴儿产后28天内的全因新生儿死亡率。通过意向治疗进行分析。将新生儿死亡率与广义估计方程进行比较。研究结果从2011年2月15日至2013年1月30日，我们筛选了42 356名孕妇，并招募了39 679名妇女（平均436人）。ClinicalTrials.gov每群2例[SD 65.3]），其中活产37 856例，死产723例; 63.8%的分娩是在医院进行的。在活产婴儿中，氯己定组的18450名（99.7%）新生儿和干脐带护理组的19308名（99.8%）新生儿随访至第28天或死亡。洗必泰组16660例（90.0%）婴儿在出生后24 h内使用洗必泰。我们发现洗必泰组（每1000例活产15.2例死亡）和干脐带护理组（每1000例活产13.6例死亡;风险比[RR] 1.12，95%CI 0.88-1.44）的新生儿死亡率无显著差异。排除第0天的死亡产生了类似的结果（RR 1.12，95%CI 0.86-1.47）。解释尽管以前在南亚报告的大幅减少，氯己定脐带应用并没有显着降低新生儿死亡率在赞比亚。氯己定脐带的应用似乎没有为新生儿提供明显的好处，主要是在设施分娩和较低的新生儿死亡率（< 30每1000活产死亡）的环境。版权所有（C）作者。爱思唯尔有限公司出版
Background Chlorhexidine umbilical cord washes reduce neonatal mortality in south Asian populations with high neonatal mortality rates and predominantly home-based deliveries. No data exist for sub-Saharan African populations with lower neonatal mortality rates or mostly facility-based deliveries. We compared the effect of chlorhexidine with dry cord care on neonatal mortality rates in Zambia.Methods We undertook a cluster-randomised controlled trial in Southern Province, Zambia, with 90 health facility-based clusters. We enrolled women who were in their second or third trimester of pregnancy, aged at least 15 years, and who would remain in the catchment area for follow-up of 28 days post-partum. Newborn babies received clean dry cord care (control) or topical application of 10 mL of a 4% chlorhexidine solution once per day until 3 days after cord drop (intervention), according to cluster assignment. We used stratified, restricted randomisation to divide clusters into urban or two rural groups (located < 40 km or >= 40 km to referral facility), and randomly assigned clusters (1: 1) to use intervention (n=45) or control treatment (n=45). Sites, participants, and field monitors were aware of their study assignment. The primary outcomes were all-cause neonatal mortality within 28 days post-partum and all-cause neonatal mortality within 28 days post-partum among babies who survived the first 24 h of life. Analysis was by intention to treat. Neonatal mortality rate was compared with generalised estimating equations. This study is registered at ClinicalTrials.gov (NCT01241318).Findings From Feb 15, 2011, to Jan 30, 2013, we screened 42 356 pregnant women and enrolled 39 679 women (mean 436 . 2 per cluster [SD 65.3]), who had 37 856 livebirths and 723 stillbirths; 63.8% of deliveries were facility-based. Of livebirths, 18 450 (99.7%) newborn babies in the chlorhexidine group and 19 308 (99.8%) newborn babies in the dry cord care group were followed up to day 28 or death. 16 660 (90.0%) infants in the chlorhexidine group had chlorhexidine applied within 24 h of birth. We found no significant difference in neonatal mortality rate between the chlorhexidine group (15.2 deaths per 1000 livebirths) and the dry cord care group (13.6 deaths per 1000 livebirths; risk ratio [RR] 1.12, 95% CI 0.88-1.44). Eliminating day 0 deaths yielded similar findings (RR 1.12, 95% CI 0.86-1.47).Interpretation Despite substantial reductions previously reported in south Asia, chlorhexidine cord applications did not significantly reduce neonatal mortality rates in Zambia. Chlorhexidine cord applications do not seem to provide clear benefits for newborn babies in settings with predominantly facility-based deliveries and lower (< 30 deaths per 1000 livebirths) neonatal mortality rates. Copyright (C) The Author(s). Published by Elsevier Ltd.