Potential Lives Saved/Year: Hundreds of thousands of newborns¹
Problem and Proposed Intervention
Globally, neonatal sepsis accounts for over 500,000 newborn deaths annually1. Many of these infections come from contamination of the umbilical cord stump. Chlorhexidine (CHX) digluconate is a widely used, low-cost antiseptic effective against major agents of neonatal infection. Since its introduction in the 1950s, it has been used regularly as a surgical, veterinary, neonatal and dental antiseptic and carefully studied for safety and efficacy. Recent community-level randomized controlled trials in Nepal2, Pakistan3,4, and Bangladesh3,4 have shown that applying a 4% CHX product (7.1% CHX digluconate) to the umbilical cord saves lives. Across the three countries, data from over 54,000 newborns showed an aggregate 23% reduction in neonatal mortality (not including deaths in the first few hours of life) and a 68% reduction in severe infections for the CHX intervention groups2,3,4. The results are some of the largest effect sizes seen in any neonatal intervention. CHX has a long shelf life, requires no cold chain, and is extremely easy to apply with minimal training and no equipment. These factors make it suitable for hospital, health center, and home care alike. Few other interventions have demonstrated such potential for rapidly reducing newborn mortality across so many settings for such a low cost. Action is necessary to prioritize increased use of this overlooked intervention, thereby contributing to hundreds of thousands of newborn lives saved annually.
See also the work that the Chlorhexidine Working Group is doing.
Chlorhexidine (CHX) product characteristics:
|Drug:||Chlorhexidine gluconate (also called Chlorhexidine digluconate or just Chlorhexidine)|
|Proposed Indication:||Antiseptic for umbilical cord care/cleansing|
|Formulation:||7.1% CHX digluconate aqueous solution or gel, delivering 4% CHX for umbilical cord care|
|Dose:||3 grams for single day application (as currently practiced in Nepal)|
|Avg. Cost:||Around $0.30 (as currently sold in Nepal)5|
Initial Findings from Product Case Study Working Paper
* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product. The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.
- Black RE, Cousens S, Johnson HL, Lawn JE, et al. Global, regional and national causes of mortality in 2008: a systematic analysis. Lancet 2010; 375:1969-1987.
- Mullany LC, Darmstadt GL, Khatry SK, et al. Topical applications of chlorhexidine to the umbilical for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomized trial. The Lancet. 2006;367:910–918.
- Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. The Lancet. Published online February 8, 2012.
- El Arifeen S, Mullany LC, Shah R, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. The Lancet. Published online February 8, 2012.
- This cost estimate includes the active drug cost of less than $0.01 plus packaging costs.
- World Health Organization. Care of the Umbilical Cord: A Review of the Evidence. Geneva: WHO/RHT/MSM; 1999. Available at: https://apps.who.int/rht/documents/MSM98-4/MSM-98-4.htm.
- WHO. WHO Model List of Essential Medicines (March 2011), 17th edition. Available at: http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf. Accessed March 26,2011
- WHO. Priority Medicines for Mothers and Children 2011, 3rd edition. http://www.who.int/medicines/publications/A4prioritymedicines.pdf (Accessed March 2012)