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.

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Date

Randomized Trials

Study Country Design Study Size(Live Births)

CHXIntervention

Mullany et al.(2006) Nepal

Community-based, cluster randomized, 2x3 factorial trial (skin x cord cleansing)

CHX: 4,934Soap: 5,107Dry Care: 5,082

Applied by study staff on 7 or first 10 days.

Baqui et al. BangladeshCommunity-based, cluster randomized trial

CHX x 7d: ~9,600CHS x 1d: ~9,600Dry 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: ~1,200Usual Care: ~1,200

Given to mother by TBA to apply for first 14 days.

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Date

Randomized Trials

Study Country

ResultsNeonatal Mortality

ResultsSevere 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. Bangladesh Unpublished Unpublished

Bhutta et al. Pakistan Unpublished Unpublished

Pooled 3 trialsUnpublished, consistent results(15% - 25% reductions)

Unpublished, consistent results for all severity levels of cord infection

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Randomized Trials of Skin CleansingHospital-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)

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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.