Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- Skin flora reduction across treatment groups
Study Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 3 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •babies born at Tribhuvan University Teaching Hospital
- •greater than 1500 grams
Exclusion Criteria
- •less than 1500 grams
- •requires major surgical procedure
- •clinically evident skin infection
- •generalized skin disease
- •major congenital anomoly
Arms & Interventions
CHX 1.0%
1.0% CHX wiping
Intervention: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) (Procedure)
CHX 0.5%
0.5% Chlorhexidine
Intervention: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) (Procedure)
CHX 0.25%
chlorhexidine cleansing with pre-soaked pre-sealed wipe
Intervention: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) (Procedure)
Outcomes
Primary Outcomes
Skin flora reduction across treatment groups
Time Frame: prior to wipe, 2hrs after, and 24hrs after
Secondary Outcomes
- Serum concentrations of chlorhexidine 24 hours after wipe(24 hrs after wipe)