Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

NCT ID: NCT00271440

Last Updated: 2010-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2006-04-30

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

Conditions

Bacterial Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CHX 1.0%

1.0% CHX wiping

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

CHX 0.5%

0.5% Chlorhexidine

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

CHX 0.25%

chlorhexidine cleansing with pre-soaked pre-sealed wipe

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Interventions

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tribhuvan University, Nepal

OTHER

Sponsor Role: collaborator

Nepal Nutrition Intervention Project Sarlahi

OTHER

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Principal Investigators

Luke C Mullany, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Tribhuvan University Teaching Hospital

Kathmandu, , Nepal

Countries

Nepal

Other Identifiers

R01HD044004

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01-HD44004-2

Identifier Type: -

Identifier Source: org_study_id