Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

Bacterial Infection Clinical Trial

— NNIPS-SFS  

Official title:

Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271440
• Other study ID #: R01-HD44004-2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 29, 2005
• Last updated: April 2, 2010
• Start date: January 2006
• Est. completion date: April 2006

Study information

• Verified date: April 2010
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardNepal: Institute of Medicine, Tribhuvan University
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections

Intervention

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

Locations

Country	Name	City	State
Nepal	Tribhuvan University Teaching Hospital	Kathmandu

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Nepal Nutrition Intervention Project Sarlahi, Tribhuvan University, Nepal

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin flora reduction across treatment groups		prior to wipe, 2hrs after, and 24hrs after	No
Secondary	Serum concentrations of chlorhexidine 24 hours after wipe		24 hrs after wipe	Yes