与使用氯己定粉末相比，新生儿采用脐带干燥护理时脐带相关不良事件发生率更高。一项比较氯己定粉末与干燥护理在新生儿脐带护理中疗效和安全性的随机对照研究结果。

Higher rate of cord-related adverse events in neonates with dry umbilical cord care compared to chlorhexidine powder. Results of a randomized controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn.

作者信息

Kapellen Thomas M, Gebauer Corinna M, Brosteanu Oana, Labitzke Birgit, Vogtmann Christoph, Kiess Wieland

机构信息

Hospital for Children and Adolescents, University of Leipzig, Liebigstrasse 20A Leipzig DE-04103, Germany.

出版信息

Neonatology. 2009;96(1):13-8. doi: 10.1159/000200165. Epub 2009 Feb 7.

DOI:10.1159/000200165

PMID:19202343

Abstract

OBJECTIVE

Best practice for umbilical cord care (UC) still remains controversial in developed countries with aseptic perinatal care. A bicenter randomized clinical trial was performed to evaluate the efficacy of chlorhexidine (CX) powder versus dry cord care (DC) for UC.

PATIENTS AND METHODS

All neonates of two neonatal care units were invited to take part in the study. Participants were randomized to either DC or UC with CX powder (0.1%). Primary study outcome was the cord separation time. Secondary outcomes were omphalitis, granuloma of the umbilical ground, adverse events and parents' treatment satisfaction. The outcome parameters were documented at a hospital-located study visit 10-14 days after birth.

RESULTS

669 neonates were enrolled in the trial. 337 were randomized to receive CX powder for umbilical cord care, 332 to DC. Cord separation time was 7.0 +/- 2.5 days in CX-treated neonates and 7.8 +/- 2.9 days in DC (p < 0.001). There were 9 cases of omphalitis, 2 in the CX group, 7 in the DC group (p = 0.1). No difference in the occurrence of umbilical granuloma between the treatment regimens was detected. Neonates randomized to CX were less likely to have an adverse event (140 in 109 subjects vs. 205 in 149 subjects in the DC neonates; p = 0.001). Half of these adverse events were cord-related. Neonates randomized to DC had nearly twice as many cord-related adverse events as those with CX treatment (CX: 58 in 54 patients vs. DC: 110 in 97 patients; p < 0.001). Parents' treatment satisfaction was significantly higher in the neonates with CX cord care.

CONCLUSIONS

Cord-related adverse events in neonatal umbilical cord care remain a clinical issue. Even in an aseptic birth context in a developed country, cord care with CX powder showed a reduction of cord-related adverse events.

摘要

目的

在围产期护理无菌的发达国家，脐带护理（UC）的最佳实践仍存在争议。进行了一项双中心随机临床试验，以评估洗必泰（CX）粉末与脐带干护理（DC）用于脐带护理的疗效。

患者与方法

邀请两个新生儿护理单元的所有新生儿参与研究。参与者被随机分为接受DC或含CX粉末（0.1%）的脐带护理组。主要研究结局为脐带脱落时间。次要结局为脐炎、脐根部肉芽肿、不良事件及家长对治疗的满意度。结局参数在出生后10 - 14天于医院进行的研究访视时记录。

结果

669名新生儿纳入试验。337名被随机分配接受CX粉末进行脐带护理，332名接受DC护理。接受CX治疗的新生儿脐带脱落时间为7.0±2.5天，接受DC护理的为7.8±2.9天（p<0.001）。发生9例脐炎，CX组2例，DC组7例（p = 0.1）。未检测到不同治疗方案之间脐带肉芽肿发生率的差异。随机分配至CX组的新生儿发生不良事件的可能性较小（109名受试者中的140例 vs. DC组149名受试者中的205例；p = 0.001）。这些不良事件中有一半与脐带相关。随机分配至DC组的新生儿与脐带相关的不良事件几乎是接受CX治疗新生儿的两倍（CX组：54例患者中的58例 vs. DC组：97例患者中的110例；p<0.001）。接受CX脐带护理的新生儿家长对治疗的满意度显著更高。