International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Bangladesh.
Lancet. 2012 Mar 17;379(9820):1022-8. doi: 10.1016/S0140-6736(11)61848-5. Epub 2012 Feb 8.
Up to half of neonatal deaths in high mortality settings are due to infections, many of which can originate through the freshly cut umbilical cord stump. We aimed to assess the effectiveness of two cord-cleansing regimens with the promotion of dry cord care in the prevention of neonatal mortality.
We did a community-based, parallel cluster-randomised trial in Sylhet, Bangladesh. We divided the study area into 133 clusters, which were randomly assigned to one of the two chlorhexidine cleansing regimens (single cleansing as soon as possible after birth; daily cleansing for 7 days after birth) or promotion of dry cord care. Randomisation was done by use of a computer-generated sequence, stratified by cluster-specific participation in a previous trial. All livebirths were eligible; those visited within 7 days by a local female village health worker trained to deliver the cord care intervention were enrolled. We did not mask study workers and participants to the study interventions. Our primary outcome was neonatal mortality (within 28 days of birth) per 1000 livebirths, which we analysed on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00434408.
Between June, 2007, and September, 2009, we enrolled 29 760 newborn babies (10 329, 9423, and 10 008 in the multiple-cleansing, single-cleansing, and dry cord care groups, respectively). Neonatal mortality was lower in the single-cleansing group (22·5 per 1000 livebirths) than it was in the dry cord care group (28·3 per 1000 livebirths; relative risk [RR] 0·80 [95% CI] 0·65-0·98). Neonatal mortality in the multiple-cleansing group (26·6 per 1000 livebirths) was not statistically significantly lower than it was in the dry cord care group (RR 0·94 [0·78-1·14]). Compared with the dry cord care group, we recorded a statistically significant reduction in the occurrence of severe cord infection (redness with pus) in the multiple-cleansing group (risk per 1000 livebirths=4·2 vs risk per 1000 livebirths=1·2; RR 0·35 [0·15-0·81]) but not in the single-cleansing group (risk per 1000 livebirths=3·3; RR 0·77 [0·40-1·48]).
Chlorhexidine cleansing of a neonate's umbilical cord can save lives, but further studies are needed to establish the best frequency with which to deliver the intervention.
United States Agency for International Development and Save the Children's Saving Newborn Lives program, through a grant from the Bill & Melinda Gates Foundation.
在高死亡率环境中，多达一半的新生儿死亡是由感染引起的，其中许多感染可能源自刚刚剪断的脐带残端。我们旨在评估两种脐带清洗方案（出生后尽快进行一次清洗；出生后连续 7 天每日清洗）联合促进脐带干燥护理对预防新生儿死亡的效果。
我们在孟加拉国锡尔赫特进行了一项基于社区的、平行的群组随机试验。我们将研究区域划分为 133 个群组，这些群组被随机分配到两种洗必泰清洗方案（出生后尽快进行单次清洗；出生后连续 7 天每日清洗）或促进脐带干燥护理。通过使用计算机生成的序列，按群组在之前试验中的特定参与情况进行分层，从而实现随机化。所有活产儿都有资格参加；当地接受过培训以提供脐带护理干预的女性乡村卫生工作者在出生后 7 天内对其进行了访视。我们未对研究工作人员和参与者实施研究干预措施的盲法。我们的主要结局是每 1000 例活产儿中的新生儿死亡率（出生后 28 天内），我们基于意向治疗原则进行了分析。本试验在 ClinicalTrials.gov 注册，编号为 NCT00434408。
在 2007 年 6 月至 2009 年 9 月期间，我们共纳入了 29760 名新生儿（多清洗组 10329 名、单清洗组 9423 名和干燥脐带护理组 10008 名）。与干燥脐带护理组（28.3/1000 例活产儿）相比，单清洗组（22.5/1000 例活产儿）的新生儿死亡率较低（相对风险 [RR] 0.80 [95%CI 0.65-0.98]）。与干燥脐带护理组相比，多清洗组（26.6/1000 例活产儿）的新生儿死亡率无统计学显著差异（RR 0.94 [0.78-1.14]）。与干燥脐带护理组相比，我们在多清洗组中记录到严重脐带感染（发红伴脓液）的发生率显著降低（每 1000 例活产儿的风险=4.2，每 1000 例活产儿的风险=1.2；RR 0.35 [0.15-0.81]），但在单清洗组中未观察到这种情况（每 1000 例活产儿的风险=3.3；RR 0.77 [0.40-1.48]）。
对新生儿脐带进行洗必泰清洗可以挽救生命，但仍需要进一步研究来确定最佳的干预实施频率。
美国国际开发署和拯救儿童会的拯救新生儿生命计划，通过比尔及梅林达·盖茨基金会的一项赠款提供资金。
