Welcome to the chlorhexidine for umbilical cord care topic page. This page provides the latest news, resources, multimedia and blogs on the use of chlorhexidine for umbilical cord care—a safe and effective intervention to prevent neonatal infection. This intervention is low cost and can be integrated into existing newborn care programs and platforms.
Use of 7.1% chlorhexidine digluconate (delivering 4% chlorhexidine) for cord care is compatible with World Health Organization (WHO) guidelines. Since 1998, the WHO has recommended the use of an antiseptic such as chlorhexidine for umbilical cord care in settings where the risk of bacterial infection is high.
Since 2007, members of the CWG have advocated for revision of the cord care guidelines to be more inclusive of effective topical antiseptics such as chlorhexidine. In September 2012, WHO convened an expert consultation to review evidence for postnatal care. The consultative meeting participants reviewed the evidence for chlorhexidine cord care and made a recommendation which was recently adopted by the WHO. In January 2014, the WHO published the Recommendations on Postnatal Care of the Mother and Newborn, which contains formal guidance on the use of 7.1% chlorhexidine digluconate for cord care.
Since 2007, members of the CWG have also advocated for inclusion of 7.1% chlorhexidine digluconate in the WHO Model List of Essential Medicines for Children (EMLc), and to this end submitted a formal application in 2008. While the review committee agreed that there was sufficient evidence on the effectiveness of 7.1% chlorhexidine digluconate, they declined to replace bulk 20% chlorhexidine digluconate with 7.1% chlorhexidine digluconate due to perceived lack of commercially available 7.1% chlorhexidine digluconate product. In 2009 and 2010, members of the CWG responded to the WHO EMLc review with supporting letters and request letters updating WHO on research and manufacturing developments. In November 2012, members of the CWG submitted a revised application with updated information on programmatic research and commercial availability of 7.1% chlorhexidine digluconate products. The WHO’s 19th Expert Committee on the Selection and Use of Medicines reviewed and approved the revised application and subsequently, 7.1% chlorhexidine digluconate for umbilical cord care was included in the July 2013 publication of the EMLc.
Country Guidance: Implementing Chlorhexidine for Umbilical Cord Care - English,French(Updated September, 2014).
Supplementary Country Guidance - English, French(Updated September, 2014)
BIBLIOGRAPHY: The CWG has compiled aselected bibliographyfor chlorhexidine that lists the evidence supporting chlorhexidine digluconate for cord care. (Updated February 2014)
CHLORHEXIDINE PRODUCTS AND USES IN HEALTH CARE: Chlorhexidine is available in different concentrations and for various indications. The 7.1% concentration that is used for umbilical cord care is a novel formulation. The CWG has developed Chlorhexidine Products and Uses in Health Care, an outline describing other existing presentations of chlorhexidine and their intended uses in health care settings. English/ Français(March 2014).
COMMUNITY-BASED RANDOMIZED TRIALS: Recent community‐based randomized trials in rural areas in Bangladesh, Nepal, and Pakistan confirm that applying 7.1% chlorhexidine digluconate (delivering 4% chlorhexidine) to the umbilical cord prevents infection and saves newborn lives. The results of these trials showed a reduction of neonatal mortality from 20% to 38%, and eliminates up to three-quarters of serious umbilical infections (omphalitis). Additionally, operational studies in Bangladesh and Nepal demonstrated that both liquid and gel forms of 7.1% chlorhexidine digluconate were acceptable to families, and that families were typically able to use the product as recommended.
Bangladesh: chlorhexidine cord cleansing on the first day of birth reduced newborn death by as much as 20%. Continuing the treatment for 7 days, although showing fewer signs of infection when compared to dry cord care, did not see a significant reduction in newborn mortality. (Lancet, March 2012)
Nepal: 24% reduction in newborn mortality when community health workers applied chlorhexidine to the cord during home visits. This intervention can be successfully incorporated into maternal and newborn care programs using existing cadre of female community health volunteers. (Lancet, March 2006)
Pakistan: When chlorhexidine was recommended and provided by traditional birth attendants to families, risk of newborn infection dropped by 42%, and neonatal mortality reduced by nearly 40%. (Lancet,March 2012)
Meta-Analysis: A meta-analysis of the three studies listed above evaluated the effect of applying chlorhexidine to the umbilical cord for the prevention of omphalitis and neonatal mortality in community settings. (BMC Public Health, September 2013)
PRODUCT AVAILABILITY: At this time, there are three sources for purchase of 7.1% chlorhexidine digluconate for umbilical cord care. All prices are subject to volume of purchase. Stated prices do not include shipping or customs clearance.
Note: Manufacturers/Suppliers may require a minimum lead time for production.
STANDARD INFORMATION FOR PATIENT INFORMATION LEAFLET: Thisdocumentis for manufacturers of the chlorhexidine product or for implementing organizations who will develop patient information leaflets in order to help them provide easily understandable, accurate, and consistent product information to users. This document does not constitute a legal interpretation of the requirements for patient information leaflets. (July 2015)
CONSIDERATIONS FOR PROCURERS: When procuring 7.1% chlorhexidine digluconate for umbilical cord care, it is important to ensure that the chlorhexidine product is produced and packaged according to standard specifications. Among other things, well-written and complete specifications help ensure that purchased products are made with high-quality materials and are produced under current good manufacturing practices (cGMP). This document outlines important considerations for procurers. (July 2015)
EXAMPLES OF PRODUCT PACKAGING: Countries scaling up chlorhexidine for umbilical cord care using the gel format of chlorhexidine have collaborated with the manufacturer to develop customized packaging, inlcuding a local product name. Examples of packaging from Liberia, Madagascar, and Nepal can be found here.
EXPLORING LOCAL PRODUCTION: The CWG believes that local production is one of the production strategies for producing chlorhexidine for cord care - locally owned manufacturers, multi-national companies based in low-resource countries, or regional manufacturers, as appropriate. 7.1% chlorhexidine digluconate (delivering 4% chlorhexidine) is relatively easy to manufacture and local production allows low-resource countries to build local drug production capacity.
Production Strategy English (Updated June 2014) / Français(Updated June 2014)
Market Sizing Tool:
Version 1: utilizes market data for selected countries based primarily on Demographic and Health Survey (DHS) data (August, 2014)
Version 2: utilizes user defined inputs, which allows users to adjust variable values to estimate market size (2012).
DILUTION INSTRUCTIONS: Step-by-step guidance for health professionals to make 7.1% chlorhexidine digluconate liquid from 20% chlorhexidine digluconate solution. (January 2014)
In addition to large-scale clinical effectiveness trials, extensive formative research and programmatic piloting has been conducted to establish and confirm the acceptability, feasibility, impact, and cost‐effectiveness of introducing a 7.1% chlorhexidine digluconate (delivering 4% chlorhexidine) product for umbilical cord care. Resources here include formative research tools and results; documentation of stakeholder meetings, strategy development, and scale-up planning; communication and training materials; and country-level case studies.
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