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Sponsors and Collaborators: |
Johns Hopkins Bloomberg School of Public Health Institute of Medicine, Tribhuvan University Nepal Nutrition Intervention Project, Sarlahi |
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Information provided by: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT00271440 |
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.
Condition | Intervention | Phase |
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Bacterial Infection |
Procedure: skin cleansing with chlorhexidine (0.25%, 0.5%, 1%) |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Effect of Chlorhexidine Cleansing on Skin Flora of Newborns in Nepal |
Estimated Enrollment: | 300 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | April 2006 |
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
Ages Eligible for Study: | up to 3 Days |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Nepal | |
Tribhuvan University Teaching Hospital | |
Kathmandu, Nepal |
Principal Investigator: | Luke C Mullany, PhD | Johns Hopkins Bloomberg School of Public Health |
Study ID Numbers: | R01-HD44004-2 |
Study First Received: | December 29, 2005 |
Last Updated: | June 16, 2006 |
ClinicalTrials.gov Identifier: | NCT00271440 |
Health Authority: | United States: Institutional Review Board; Nepal: Institute of Medicine, Tribhuvan University |
chlorhexidine neonatal skin flora skin cleansing bacterial colonization |
Bacterial Infections Chlorhexidine Chlorhexidine gluconate |
Anti-Infective Agents Anti-Infective Agents, Local Disinfectants Therapeutic Uses |
Infection Dermatologic Agents Pharmacologic Actions |