NEWBORN SKIN CLEANSING WITH A DILUTE CHLORHEXIDINE SOLUTION REDUCES NEONATAL MORTALITY IN SOUTHERN NEPAL: A COMMUNITY-BASED, RANDOMIZED TRIAL Luke Mullany, PhD Contact Luke Mullany Department of International Health, Suite #W5009 615 N. Wolfe Street Baltimore, MD 21205 United States of America ABSTRACT Background Significant progress has been made in reducing preschool child mortality in developing countries, but much less progress has occurred among those neonates at highest risk. Hospital-based data from Malawi suggested that newborn infant skin cleansing using a dilute chlorhexidine solution could reduce neonatal mortality. Objectives We conducted a community-based, cluster-randomized trial in southern Nepal to test the hypothesis that cleansing of newborn skin with a chlorhexidine solution would reduce neonatal mortality. Methods In Sarlahi District, Nepal, 413 sectors were randomized to receive either newborn skin cleansing with baby wipes which released a 0.25% chlorhexidine solution or a placebo solution. Pregnant women were recruited and consented at 6 months gestation and local women implemented the assigned treatment as soon as possible after delivery. All women received vitamin A and iron-folic acid supplementation, deworming, tetanus toxoid immunization, and detailed education on proper nutrition, hygiene and newborn thermal care. Infants were eligible for enrolment if they were alive at the time of the local workers intervention visit and the family provided consent. Infants were visited on a regular basis until day 28. The primary outcome was all-cause mortality. Findings A total of 17,306 newborn infants were enrolled, 8519 in the chlorhexidine group and 8787 in the placebo group. The average time of newborn skin cleansing was 5.8 hours after birth and over 90% received their assigned intervention within the first 24 hours. Baseline demographic, socio-economic, maternal, infant, and delivery characteristics were similar in the treatment groups. Overall, there was a non-significant 11% lower neonatal mortality rate among those who received the chlorhexidine wash compared with placebo (RR=0.89, 95% CI: 0.72-1.10). This effect was modified significantly by birth weight. Mortality risk was reduced by 28% among low birth weight (lt;2500 grams) infants (RR=0.72 95% CI: 0.55-0.95) whereas there was no difference among infants born ¡Ý2500 grams (RR=1.20, 95% CI: 0.80-1.81). Conclusions Newborn skin cleansing with a dilute chlorhexidine solution soon after delivery resulted in a 28% reduction in neonatal mortality among low birth weight infants. No effect was observed among normal birth weight infants. Policy Implications This inexpensive, simple intervention could significantly improve neonatal survival among high risk, low birth weight infants in settings where home delivery is common and the environment highly contaminated.
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