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A Randomized Controlled Trial of the Impact of Chlorhexidine Skin Cleansing on Bacterial Colonization of Hospital-Born Infants in Nepal

Mullany, Luke C. PhD*; Khatry, Subarna K. MBBS; Sherchand, Jeevan B. PhD; LeClerq, Steven C. MPH*†; Darmstadt, Gary L. MD, MS*; Katz, Joanne ScD*; Gauchan, Punita MSc; Adhikari, Ramesh K. MBBS; Rana, Ashma MBBS; Tielsch, James M. PhD*

The Pediatric Infectious Disease Journal: June 2008 - Volume 27 - Issue 6 - p 505-511
doi: 10.1097/INF.0b013e31816791a2
Original Studies

Background: Chlorhexidine skin cleansing might substantially reduce neonatal infection and mortality in developing countries. Few data exist on the impact of chlorhexidine cleansing on skin colonization of infants during the first day of life or on the absorption potential of chlorhexidine during newborn skin cleansing.

Methods: Hospital-born newborns in Kathmandu, Nepal were randomly allocated to full-body skin cleansing with 0.25%, 0.50%, or 1.00% chlorhexidine solution. Skin swabs were collected from the axilla, inguinal, and peri-umbilical areas before cleansing (baseline), and at 2 and 24 hours after treatment. Skin flora was quantified and organisms identified. In a subsample, heel prick blood was collected 24 hours after the cleansing and percutaneous absorption of chlorhexidine was assessed.

Results: Among 286 enrolled newborns, no adverse effects on skin were reported and body temperature was minimally reduced (mean reduction, 0.33°C). In all groups, positive skin culture rates were significantly reduced at 2 hours but generally not at 24 hours; greater reductions were observed with higher concentrations of chlorhexidine. Effect at 24 hours was highest in the 1.00% group (37% lower positive skin culture rate). For 15 of 75 infants with heel pricks, chlorhexidine was detected at trace concentrations (<8 ng/mL, n = 14; 25.8 ng/mL, n = 1).

Conclusions: Chlorhexidine skin cleansing seemed safe and reduced skin flora in newborns in a dose-dependent manner 2 hours after treatment. Greater residual effect at the highest concentration (1%) might provide broader benefit and may simplify combined maternal and neonatal regimens by matching the concentration used for vaginal cleansing during labor.

Supplemental Digital Content is Available in the Text.

From the *International Center for Advancing Neonatal Health, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; †Nepal Nutrition Intervention Project, Sarlahi (NNIPS); and ‡Institute of Medicine, Tribhuvan University, Kathmandu, Nepal.

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Accepted for publication January 8, 2008.

Supported by grants from the National Institutes of Health, Bethesda, MD (HD 44004, HD 38753), the Bill and Melinda Gates Foundation, Seattle, WA (810-2054), and Cooperative Agreements between JHU and the Office of Health and Nutrition, U.S. Agency for International Development, Washington, DC (HRN-A-00-97-00015-00, GHS-A-00-03-000019-00).

The above mentioned funding agencies had no role in the design and conduct of the study, the collection, management, analysis, and interpretation of the data, or in preparation, review, or approval of this article.

Address for correspondence: Luke C. Mullany, PhD, Department of International Health, Johns Hopkins Bloomberg School of Public Health. 615 N. Wolfe Street, E8646, Baltimore, MD 21205. E-mail:

© 2008 Lippincott Williams & Wilkins, Inc.