Bacterial Infection Clinical Trial
Official title:
Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
The purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in Nepal.
Studies in Malawi, Egypt, and Nepal suggest that neonatal skin cleansing with chlorhexidine
solutions may reduce the risk of infection and mortality. Cleansing with 0.25% chlorhexidine
in Nepal resulted in a 28% reduction in mortality among low birth weight infants, while
there was no impact on infants of normal weight. The mechanism of action for this observed
benefit is not clear. Chlorhexidine may remove pathogens from the skin of the newborn and/or
prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. The
benefit of chlorhexidine cleansing may be extended with higher concentrations of
chlorhexidine.
Infants born at the Tribhuvan University Teaching Hospital in Katmandu, Nepal will be
randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%,
0.50%, 1.00%). Skin swabs will be collected before wiping, and two and twenty-four hours
after wiping in order to compare levels of bacteria on the skin across the treatment groups.
A small quantity of blood will be collected at 24 hours after wiping to determine the
potential for absorption of chlorhexidine
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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