Trial reportJournal of perinatology : official journal of the California Perinatal Association2025
Antiseptic efficacy and plasma chlorhexidine levels following two different methods of application of 1% aqueous chlorhexidine gluconate for skin disinfection in preterm newborns: a randomized controlled trial.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- A Quality Improvement Bundle to Reduce Central Line-Associated Bloodstream Infections in Neonatal Intensive Care Unit: An Observational Study.Antibiotics (Basel, Switzerland) · 2025Article
- Seeing beyond the obvious: pragmatic skin care guidance for infants 22-24 weeks gestational age.Journal of perinatology : official journal of the California Perinatal Association · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveMany 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. STUDY
designParallel 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.
resultsOf 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).
conclusionCleansing 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. TRIAL REGISTRATION NUMBER: CTRI/2020/10/028719.
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Registered trials
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