Impact of newborn skin-cleansing with chlorhexidine on neonatal mortality in southern Nepal: A community-based, cluster-randomized trial
Impact of newborn skin-cleansing with chlorhexidine on neonatal mortality in southern Nepal: A community-based, cluster-randomized trial
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DOI：
10.1542/peds.2006-1192
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发表时间：
2007-02-01
期刊：
影响因子：
8
通讯作者：
Adhikari, Ramesh
中科院分区：
文献类型：
--
作者：
Tielsch, James M.;Darmstadt, Gary L.;Adhikari, Ramesh
OBJECTIVE.来自非洲的医院数据表明，新生儿用洗必泰清洁皮肤可能会降低新生儿死亡率。在大多数家庭分娩的社区，还没有对这种干预措施进行评估。我们的目的是评估0.25%洗必泰一次性清洁新生儿皮肤对新生儿死亡率的影响。该设计是在尼泊尔南部Sarlahi地区进行的一项以社区为基础的安慰剂对照随机分组试验。新生儿在家中分娩后尽快用含有0.25%氯己定或安慰剂溶液的婴儿湿巾清洁（中位数：5.8小时）。主要结局是28天内的全因死亡率。在随机阶段完成后，研究组中的所有新生儿在随后的9个月内转换为氯己定治疗。在登记的部门中，共有17530例活产，其中洗必泰组和安慰剂组分别为8650例和8880例。治疗组的基线特征相似。对所有活产婴儿的意向治疗分析显示，干预对新生儿死亡率没有影响。在实际接受指定治疗的活产婴儿中（98.7%），与安慰剂相比，使用氯己定治疗的新生儿死亡率无显著性降低11%。低出生体重儿的新生儿死亡率在统计学上显著降低了28%;出生体重≥ 2500 g的婴儿之间没有显著差异。在安慰剂组转换为积极治疗后，安慰剂组低出生体重儿的死亡率降低了37%，而氯己定组无变化。新生儿出生后立即用洗必泰溶液擦拭皮肤，仅在低出生体重儿中降低新生儿死亡率。需要更多试验的证据来确定这种廉价而简单的干预措施是否可以显着提高低出生体重儿在家庭分娩常见且卫生习惯差的环境中的存活率。
OBJECTIVE. Hospital-based data from Africa suggest that newborn skin-cleansing with chlorhexidine may reduce neonatal mortality. Evaluation of this intervention in the communities where most births occur in the home has not been done. Our objective was to assess the efficacy of a 1-time skin-cleansing of newborn infants with 0.25% chlorhexidine on neonatal mortality.METHODS. The design was a community-based, placebo-controlled, cluster-randomized trial in Sarlahi District in southern Nepal. Newborn infants were cleansed with infant wipes that contained 0.25% chlorhexidine or placebo solution as soon as possible after delivery in the home (median: 5.8 hours). The primary outcome was all-cause mortality by 28 days. After the completion of the randomized phase, all newborns in study clusters were converted to chlorhexidine treatment for the subsequent 9 months.RESULTS. A total of 17 530 live births occurred in the enrolled sectors, 8650 and 8880 in the chlorhexidine and placebo groups, respectively. Baseline characteristics were similar in the treatment groups. Intention-to-treat analysis among all live births showed no impact of the intervention on neonatal mortality. Among live-born infants who actually received their assigned treatment (98.7%), there was a nonsignificant 11% lower neonatal mortality rate among those who were treated with chlorhexidine compared with placebo. Low birth weight infants had a statistically significant 28% reduction in neonatal mortality; there was no significant difference among infants who were born weighing >= 2500 g. After conversion to active treatment in the placebo clusters, there was a 37% reduction in mortality among low birth weight infants in the placebo clusters versus no change in the chlorhexidine clusters.CONCLUSIONS. Newborn skin-wiping with chlorhexidine solution once, soon after birth, reduced neonatal mortality only among low birth weight infants. Evidence from additional trials is needed to determine whether this inexpensive and simple intervention could improve survival significantly among low birth weight infants in settings where home delivery is common and hygiene practices are poor.