Objective To evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferior for neonatal skin antisepsis. Design Parallel, blinded, non-inferiority randomised trial. Setting Level III, academic, neonatal intensive care unit. Patients Infants born at 260/7 to 426/7 weeks of gestation from June 2019 to December 2019. Interventions Participants were randomised to skin antisepsis by either 1% aqueous CHG or 2% aqueous CHG. Main outcome measures The primary outcome was the proportion of negative skin swab cultures after skin antisepsis. Secondary outcomes were local skin reactions at 0, 6, 12 and 24 hours and plasma chlorhexidine levels in a subset of the study population. Results A total of 308 neonates with a median gestation age of 34 (31–37) weeks and mean birth weight of 2029 g were randomised on 685 occasions (1% CHG: n=341; 2% CHG: n=344). 93.0% of the post-antisepsis skin swabs were sterile in 1% CHG group compared with 95.6% of the swabs in the 2% CHG group (risk difference −2.7%, 95% CI −6.2% to +0.8%). The lower bound of 95% CI crossed the pre-specified absolute non-inferiority limit of 5%. Neonates developed mild dermatitis on 16 (2.3%) occasions. There was no significant difference in median plasma CHG levels in the two groups, 19.6 (12.5–36.4) and 12.6 (8.7–26.6) ng/mL, respectively. Conclusions Application of 1% aqueous CHG was not shown to be non-inferior to 2% chlorhexidine aqueous for skin antisepsis in neonates. There were no severe skin-related adverse events in either of the two groups. Trial registration number CTRI/2019/06/019822; () Data are available on reasonable request. Deidentified individual participant data (including data dictionaries) that underlie the results reported in this article will be made available on publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to ra.aiims@gmail.com.

中文翻译：

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用于新生儿皮肤消毒的 1% 与 2% 氯己定水溶液：一项随机非劣效性试验

目的 评估 1% 葡萄糖酸氯己定水溶液 (CHG) 与 2% 葡萄糖酸氯己定水溶液相比是否不劣于新生儿皮肤消毒。设计平行、盲法、非劣效性随机试验。设置三级，学术，新生儿重症监护病房。患者 2019 年 6 月至 2019 年 12 月在 260/7 至 426/7 周出生的婴儿。 干预措施 参与者随机接受 1% CHG 水溶液或 2% CHG 水溶液进行皮肤消毒。主要结果指标主要结果是皮肤消毒后皮肤拭子培养阴性的比例。次要结果是 0、6、12 和 24 小时的局部皮肤反应以及一部分研究人群的血浆氯己定水平。结果 共有 308 名中位胎龄为 34 (31–37) 周、平均出生体重为 2029 g 的新生儿在 685 次随机分组（1% CHG：n=341；2% CHG：n=344）。1% CHG 组 93.0% 的消毒后皮肤拭子无菌，而 2% CHG 组为 95.6%（风险差异 -2.7%，95% CI -6.2% 至 +0.8%）。95% CI 的下限超过了预先指定的 5% 的绝对非劣效性限制。新生儿有 16 次 (2.3%) 出现轻度皮炎。两组的中位血浆 CHG 水平无显着差异，分别为 19.6 (12.5–36.4) 和 12.6 (8.7–26.6) ng/mL。结论 对于新生儿皮肤消毒，1% CHG 水溶液的应用并未显示出不劣于 2% 氯己定水溶液。两组均未发生严重的皮肤相关不良事件。试验注册号CTRI/2019/06/019822；() 可应合理要求提供数据。作为本文报告结果基础的去标识化个人参与者数据（包括数据字典）将在出版时提供给提供方法上合理的建议以用于实现已批准建议的目标的研究人员。提案应提交至 ra.aiims@gmail.com。