Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

Phase 1

Completed

• Conditions: Bacterial Infection
• Interventions: Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)

• Registration Number: NCT00271440
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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 Timeline

• Study First Submitted: 2005-12-29
• Study First Submitted QC: 2005-12-29
• Study Start: 2006-01
• Study First Posted: 2006-01-02
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-02
• Last Update Posted: 2010-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHX 1.0%	skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)	1.0% CHX wiping
CHX 0.5%	skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)	0.5% Chlorhexidine
CHX 0.25%	skin cleansing with chlorhexidine (0.25%, 0.5%, 1%)	chlorhexidine cleansing with pre-soaked pre-sealed wipe

Primary Outcome Measures

Name	Time	Method
Skin flora reduction across treatment groups	prior to wipe, 2hrs after, and 24hrs after

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of chlorhexidine 24 hours after wipe	24 hrs after wipe

Trial Locations

Locations (1)

Tribhuvan University Teaching Hospital; 🇳🇵 Kathmandu, Nepal