Mullany Luke C, Darmstadt Gary L, Khatry Subarna K, LeClerq Steven C, Katz Joanne, Tielsch James M
Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, 615 N Wolfe St, W5009, Baltimore, MD 21211, USA.
Pediatrics. 2006 Nov;118(5):1864-71. doi: 10.1542/peds.2006-1091.
Within a community-based, cluster-randomized study of the effects of 4.0% chlorhexidine on omphalitis and mortality risk, we aimed to describe the distribution of times to separation and the impact of topical chlorhexidine treatment on cord-separation times.
Between November 2002 and March 2005, 15123 infants were assigned randomly within communities in southern Nepal to receive 1 of the following 3 cord-care regimens: cleansing with 4.0% chlorhexidine, cleansing with soap and water, or dry cord care. In intervention clusters, field workers cleansed the cord in the home on days 1, 2, 3, 4, 6, 8, and 10 after birth. Newborns were monitored throughout the newborn period for signs of omphalitis, and the time to cord separation was noted. Separation times were compared across treatment groups. Cord infection risk and a range of infant and household characteristics were assessed for their relationships to separation time.
The mean separation time was shorter in dry cord care (4.24 days) and soap/water (4.25 days) clusters than in chlorhexidine clusters (5.32 days; mean difference: 1.08 days). Cords of infants who received chlorhexidine were 3.6 times more likely to separate after 7 days. Separation time was not associated with omphalitis. Home-delivered topical antiseptics, facility-based birth, and birth attendant hand-washing were associated with greater likelihoods of cord separation after 7 days of age.
In this setting, the umbilical cord separated more rapidly than observed in hospital-based studies, and the impact of chlorhexidine cleansing on separation times was negligible. Increased cord-separation time attributable to topical chlorhexidine treatment should not be considered a factor in decision-making in settings where the baseline risk of omphalitis is high and chlorhexidine might reduce infection and mortality risks significantly.
在一项基于社区的、群组随机化研究中，研究4.0%氯己定对脐炎和死亡风险的影响，我们旨在描述脐带脱落时间的分布情况以及局部应用氯己定治疗对脐带脱落时间的影响。
2002年11月至2005年3月期间，在尼泊尔南部的社区内随机分配15123名婴儿，使其接受以下3种脐带护理方案中的一种：用4.0%氯己定清洗、用肥皂和水清洗或脐带干燥护理。在干预群组中，现场工作人员在婴儿出生后的第1、2、3、4、6、8和10天在家中清洗脐带。在整个新生儿期对新生儿进行脐炎迹象监测，并记录脐带脱落时间。比较各治疗组的脱落时间。评估脐带感染风险以及一系列婴儿和家庭特征与脱落时间的关系。
脐带干燥护理组（4.24天）和肥皂/水清洗组（4.25天）的平均脱落时间比氯己定组（5.32天；平均差异：1.08天）短。接受氯己定治疗的婴儿脐带在7天后脱落的可能性高3.6倍。脱落时间与脐炎无关。在家中使用局部防腐剂、在医疗机构出生以及接生人员洗手与7日龄后脐带脱落的可能性增加有关。
在这种情况下，脐带脱落比在医院研究中观察到的更快，氯己定清洗对脱落时间的影响可忽略不计。在脐炎基线风险高且氯己定可能显著降低感染和死亡风险的情况下，不应将局部应用氯己定治疗导致的脐带脱落时间延长视为决策因素。
