Dalai Richie, Mohapatra Sarita, Velpandian Thirumurthy, Sankar Jeeva, Thukral Anu, Verma Ankit, Bajpai Minu, Dhinakaran R, Tousifullah Mohammad, Agarwal Ramesh
Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.
J Perinatol. 2025 Jan;45(1):128-133. doi: 10.1038/s41372-024-02122-y. Epub 2024 Sep 20.
Many neonatal units have started using Chlorhexidine gluconate for neonatal skin antisepsis. However, there is in-vitro evidence of inhibition of neurite growth. The current study aimed to compare two methods of its local application, for the extent of systemic absorption and antiseptic efficacy.
Parallel group, blinded, randomised trial, at a Level III, neonatal intensive care unit. Between December 2020 to July 2022, neonates from 28 to 34 weeks gestation, were randomized to local skin antisepsis by either- (a) 1% aqueous chlorhexidine (CHG aq) followed by cleansing off the residual agent with sterile water swab (Cleansing group) or (b)1% CHG aq followed by air drying (No cleansing group). The outcome measures were the proportion of post antisepsis skin swabs with no/insignificant growth, and the plasma chlorhexidine levels.
Of the total of 457 enrollments (Cleansing: n = 230; No Cleansing: n = 227), 216 (93.91%) in "Cleansing" vs. 221 (97.36%) in "No cleansing" (risk difference -3.45%, 95% CI -7.2 to 0.28%; p = 0.072) had no/insignificant growth post-antisepsis. The lower bound of the confidence interval crossed the pre-specified non-inferiority limit of 5%. The median (IQR) plasma chlorhexidine levels were not significantly different between the two groups (7.9 (5.6, 17.9)) ng/mL in Cleansing vs. 6.5 (4.6, 17.7) in No cleansing groups (p = 0.437).
Cleansing with sterile water after application of chlorhexidine in preterm neonates was not shown to be non-inferior compared to no cleansing, for skin antisepsis efficacy. Systemic absorption occurred to a similar extent despite cleansing off the residual agent.
CTRI/2020/10/028719.
许多新生儿病房已开始使用葡萄糖酸氯己定进行新生儿皮肤消毒。然而，有体外证据表明其会抑制神经突生长。本研究旨在比较两种局部应用方法在全身吸收程度和消毒效果方面的差异。
在一家三级新生儿重症监护病房进行平行组、双盲、随机试验。2020年12月至2022年7月期间，将妊娠28至34周的新生儿随机分为两组进行局部皮肤消毒：（a）用1%的氯己定水溶液（CHG aq），然后用无菌水棉签清除残留剂（清除组）；（b）用1%的CHG aq，然后自然晾干（不清除组）。观察指标为消毒后皮肤拭子无/轻微生长的比例以及血浆氯己定水平。
在总共457例入组病例中（清除组：n = 230；不清除组：n = 227），“清除组”中有216例（93.91%），“不清除组”中有221例（97.36%）在消毒后无/轻微生长（风险差异-3.45%，95%置信区间-7.2至0.28%；p = 0.072）。置信区间的下限超过了预先设定的5%的非劣效性界限。两组的血浆氯己定水平中位数（四分位间距）无显著差异（清除组为7.9（5.6，17.9）ng/mL，不清除组为6.5（4.6，17.7）ng/mL，p = 0.437）。
对于早产新生儿，应用氯己定后用无菌水清除残留剂在皮肤消毒效果方面并不优于不清除。尽管清除了残留剂，但全身吸收程度相似。
CTRI/2020/10/028719。
