To evaluate whether daily octenidine skin cleansing reduces the incidence of late-onset sepsis (LOS) compared with sterile water cleansing in neonates admitted to the NICU.
Approach:
Study Design: A single-center, open-label, parallel-group randomized clinical trial conducted over 2 years in a tertiary hospital in India.
Participants: Neonates of all gestational ages admitted within 48 hours of birth, excluding those with parental refusal, preexisting skin lesions, early-onset sepsis, or early discharge.
Interventions: Random assignment to either once-daily full-body cleansing with octenidine wipes or sterile water.
Randomization: Computer-generated randomization with allocation concealment using sealed envelopes.
Blinding: Outcome assessors were blinded to minimize detection bias.
Key Findings:
Octenidine has demonstrated faster bactericidal activity and longer residual activity compared to chlorhexidine in previous studies.
Inconsistent results have been reported regarding chlorhexidine's efficacy in reducing sepsis rates despite its effectiveness in reducing skin colonization.
There is limited evidence on the safety and efficacy of octenidine specifically in neonatal populations.
Interpretation:
This study aims to evaluate the effectiveness of octenidine for preventing late-onset sepsis in neonates, particularly in low- and middle-income countries.
Limitations:
The study is limited to a single center, which may affect generalizability.
Complete blinding of parents and healthcare professionals was not feasible due to the nature of the intervention.
Conclusion:
The trial aims to provide insights into the effectiveness of octenidine for cleansing in reducing late-onset sepsis in neonates.
