Impact of Newborn Skin-Cleansing With Chlorhexidine on Neonatal Mortality in Southern Nepal: A Community-Based, Cluster-Randomized Trial

Abstract

Cleaning the newborn infant's skin with chlorhexidine may lower neonatal deaths, as suggested by hospital data from Africa, but this intervention has not been tested in communities where most births take place at home. The underlying supposition is that early neonatal sepsis is associated with colonization of the infant's skin by organisms in the vaginal canal. The present study was a community-based, placebo-controlled, cluster-randomized trial carried out in southern Nepal, where newborn infants were cleansed once with wipes containing either 0.25% chlorhexidine (n = 8650) or placebo solution (n = 8880). The treatment was carried out as soon as possible after delivery at home; the median interval was just under 6 hours. The primary outcome was mortality from all causes within 4 weeks after birth. Baseline characteristics were similar in the treatment and placebo groups. Following the randomized phase of the trial, for a period of 9 months, all newborn infants were actively treated. Intent-to-treat analysis of all live births demonstrated no substantial difference in neonatal mortality. For those infants who received their assigned treatment (98.7% of the total), neonatal mortality was 11% lower after chlorhexidine washing-not a significant effect. However, low-birth-weight (LBW) infants, those with a birth weight of less than 2500 g, experienced a significant 28% decrease in neonatal mortality when cleansed with chlorhexidine. The relative risk was 0.72, with a 95% confidence interval of 0.55-0.95. Similar results were obtained in LBW infants when the criterion was a birth weight less than 2000 g, but no such difference was found in normal-birth-weight infants. Conversion of all newborn infants to active treatment was accompanied by a 37% decline in mortality for those LBW infants initially assigned to receive placebo. The efficacy of skin cleansing did not depend on whether or not the birth attendant washed her hands before delivery. It is to be hoped that further trials will confirm that chlorhexidine washing-a simple and inexpensive measure-does in fact enhance the survival of LBW infants who are born at home and those living in places where hygienic practices are suboptimal.