Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal (NNIPS-SFS)

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bacterial Infection

Treatments: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

Study type: Interventional

Funder types: Other

Identifiers

NCT00271440

R01-HD44004-2

Details and patient eligibility

About

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.

Full 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

Enrollment: 286 patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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286 participants in 3 patient groups

CHX 1.0%

Experimental group

Description:

1.0% CHX wiping

Treatment:

Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

CHX 0.5%

Experimental group

Description:

0.5% Chlorhexidine

Treatment:

Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

CHX 0.25%

Experimental group

Description:

chlorhexidine cleansing with pre-soaked pre-sealed wipe

Treatment:

Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)