Octenidine Skin Cleansing Does Not Reduce Late-Onset Neonatal Sepsis: JAMA
India: Researchers have discovered in a recent randomized clinical trial that daily skin cleansing with octenidine wipes did not reduce the incidence of late-onset sepsis (LOS) among neonates in the NICU compared with cleansing with sterile water. The findings, published in JAMA Network Open, suggest that preventing neonatal infections requires multimodal infection-control strategies rather than relying solely on antiseptic skin cleansing.
The study, led by Shreya Udavant from the Department of Paediatrics, Bharati Vidyapeeth Deemed University and Medical College, Pune, India, evaluated whether daily skin cleansing with 0.1% octenidine dihydrochloride wipes could lower the risk of LOS compared with sterile water in neonates admitted to the neonatal intensive care unit (NICU). Although octenidine has shown promise in reducing healthcare-associated infections, its effectiveness in preventing neonatal sepsis has remained uncertain.
Researchers conducted a single-center, open-label, randomized clinical trial in the level II and III NICUs of a tertiary care hospital in India between September 2023 and August 2025. The study enrolled 530 neonates admitted within 48 hours of birth without early-onset sepsis or pre-existing skin lesions. Infants were randomly assigned to receive daily whole-body cleansing with either 0.1% octenidine wipes (266 neonates) or sterile water with sterile gauze (264 neonates) until discharge, transfer, or death, with skin integrity monitored using the Neonatal Skin Condition Score.
The primary outcome was late-onset sepsis occurring more than 72 hours after birth through 28 days of life, while secondary outcomes included LOS at 7 and 14 days, all-cause mortality, NICU stay duration, and adverse skin reactions.
Key findings from the trial include:
- Late-onset sepsis occurred in 14.7% of neonates in the octenidine group and 12.9% in the sterile water group, with no significant difference between the groups (relative risk, 1.10;).
- Time to development of LOS was also comparable between the two groups (hazard ratio, 1.11).
- Rates of LOS by 7 days and 14 days were similar in both treatment arms.
- All-cause mortality and median NICU stay did not differ significantly between groups.
- Both interventions demonstrated a favorable safety profile, with adverse skin reactions occurring in 5.6% of neonates receiving octenidine and 6.1% receiving sterile water.
The researchers acknowledged several limitations, including the inability to blind caregivers, the absence of serial skin colonization cultures, the use of sterile water as the comparator, and the single-center design. They also noted the relatively mature study population, the use of unadjusted analyses, and the need for larger multicenter trials to detect smaller but clinically meaningful effects.
The authors concluded that daily octenidine skin cleansing did not reduce the incidence of late-onset sepsis compared with sterile water, although both interventions were safe. They suggested that sterile water is a reasonable option for routine neonatal skin cleansing and emphasized that infection prevention should prioritize multimodal strategies, including hand hygiene, catheter care bundles, and antibiotic stewardship, rather than skin antisepsis alone.
Reference:
Udavant S, Patnaik S, Lalwani S, Suryawanshi P, Deshmukh R. Octenidine or Sterile Water Cleansing and Late-Onset Sepsis in Neonates in the NICU: A Randomized Clinical Trial. JAMA Netw Open. 2026;9(7):e2623096. doi:10.1001/jamanetworkopen.2026.23096
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