Department of International Health Chlorhexidine Umbilical Cord Antisepsis and Neonatal Outcomes: Current Evidence James Tielsch, Ph.D. Bangkok, March 2010

Chlorhexidine Umbilical Cord Antisepsis Background Chlorhexidine is a safe and effective antiseptic agent for use in humans. Widely used in hospital settings to reduce IV line associated nosocomial infections. Umbilical cord infection is common and associated with increased risk of neonatal mortality. Significant proportion of births occur at home or in settings without optimal hygienic delivery practices. Simple, low cost approaches are needed to complement the movement to facility-based delivery.

Presenter’s Name Date Randomized Trials StudyCountryDesign Study Size (Live Births) CHX Intervention Mullany et al.(2006)Nepal Community-based, cluster randomized, 2x3 factorial trial (skin x cord cleansing) CHX: 4,934 Soap: 5,107 Dry Care: 5,082 Applied by study staff on 7 or first 10 days. Baqui et al.Bangladesh Community-based, cluster randomized trial CHX x 7d: ~9,600 CHS x 1d: ~9,600 Dry Care: ~9,600 Applied by study staff on either first day or for first 7 days. Bhutta et al. Pakistan Community-based, cluster randomized trial, 2x2 factorial trial (CHX to cord and hand washing) CHX: ~1,200 Usual Care: ~1,200 Given to mother by TBA to apply for first 14 days.

Presenter’s Name Date Randomized Trials StudyCountry Results Neonatal Mortality Results Severe Omphalitis Mullany et al. (2006) Nepal CHX vs Dry: RR=0.76 (0.55, 1.04) Soap vs Dry: RR=1.00 (0.76, 1.31) CHX vs Dry: RR=0.25 (0.12, 0.53) Soap vs Dry: RR=1.01 (0.58, 1.77) Baqui et al.BangladeshUnpublished Bhutta et al.PakistanUnpublished Pooled3 trials Unpublished, consistent results (15% - 25% reductions) Unpublished, consistent results for all severity levels of cord infection

Presenter’s Name Date Randomized Trials of Skin Cleansing Hospital-based trials in Africa. Malawi (Taha et al., 1997) Sequential periods of hospital births to vaginal wash plus infant body wash (0.25% CHX) or normal care. RR (mortality)=0.78 (0.60 to 1.00). Egypt (Bakr et al., 2005) Same design as Malawi Significant reduction in early infant mortality. South Africa (Cutland et al., 2009) No impact, but mortality very low and hygienic delivery. Community-based trial in Asia. Nepal (Tielsch et al., 2007) Cluster randomized trial. RR (neonatal mortality)=0.89 (0.72–1.10) Among LBW, RR=0.72 (0.55–0.95)

Presenter’s Name Date Conclusions Trials from Asia provide strong evidence that chlorhexidine antisepsis to the umbilical cord can reduce neonatal mortality and omphalitis. Two trials are beginning in Africa (Tanzania and Zambia). Early application is key to achieving optimal benefit. Formulations and application regimens may vary according to community preferences. Nepal had done work on this issue. Total body newborn skin cleansing with CHX also potentially beneficial, but momentum lacking. Chlorhexidine umbilical cord antisepsis is a highly cost- effective intervention that can assist countries in meeting MDG-4.