Application of chlorhexidine to the umbilical cord after birth in low-income settings: two randomised controlled trials.

ed from El Arifeen S, Mullany LC, Shah R. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a communitybased, cluster-randomised trial.. Lancet2012;379:1022–8. Source(s) of funding USA Agency for International Development. Study design Design: Community-based cluster-randomised trial. Allocation: Clusters were computer randomised by a statistician not involved in recruitment of patients. There were 187 clusters, with a mean population of 1000 people. Blinding: Implementation and data collection teams were masked to allocation. Study question Setting: Rural area of Pakistan. Patients: All liveborn babies were eligible for enrolment. Newborns with obvious congenital defects or cord anomalies were excluded. Of 11 886 eligible infants, 9741 were enrolled. Almost 90% of families applied traditional remedies on the cord. Baseline characteristics were similar between the four groups. Intervention: Clusters were randomised to four groups: topical 4% chlorhexidine daily for 14 days plus hand washing with antiseptic soap and water, hand washing and dry cord care, chlorhexidine without hand-washing recommendations, and dry cord care without hand-washing recommendations (control group). Outcomes: Primary outcomes were neonatal omphalitis and mortality. Follow-up period: Outcomes were assessed at days 1, 3, 5, 7, 14 and 28. Patient follow-up: An intention-to-treat analysis was performed. Final health status was available for over 95% of patients enrolled. Main results Risk of omphalitis was lower in all treatment groups. There was a trend of a lower risk of mortality in the chlorhexidine groups, but no statistically significant difference was found. There were no serious adverse effects (table 2). Conclusion Topical chlorhexidine and hand washing reduced risk of omphalitis. Abstracted from Soofi S, Cousens S, Imdad A, et al. 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. Lancet 2012;379:1029–36.ed from Soofi S, Cousens S, Imdad A, et al. 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. Lancet 2012;379:1029–36. Source(s) of funding PAIMAN (Pakistan Initiative for Mothers and Newborns) and John Snow Inc. Table 1 Cord infection and mortality risks Severe redness with pus* Mortality* Mortality risk† Multiple chlorhexidine 0.35 (0.15 to 0.81) 0.94 (0.78 to 1.14) 26.6 Single chlorhexidine 0.77 (0.40 to 1.48) 0.80 (0.65 to 0.98) 22.6 Dry cord care 1 1 28.3 *Relative risk (95% CI); †Risk per 1000 livebirths. Table 2 Cord infection and mortality risks Omphalitis* Mortality* Mortality risk† Chlorhexidine +hand washing 0.53 (0.32 to 0.88) 0.64 (0.39 to 1.06) 20.3 Hand washing +dry cord care 0.67 (0.48 to 0.93) 1.23 (0.82 to 1.83) 38.4 Chlorhexidine 0.44 (0.29 to 0.67) 0.74 (0.50 to 1.08) 24.9 Dry cord care 1 1 33.8 *Relative risk (95% CI); †Risk per 1000 livebirths. Arch Dis Child Educ Pract Ed 2012;0:1–2. doi:10.1136/archdischild-2012-302621 1 STRUCTURED ABSTRACTS OF SENTINEL ARTICLES: PICKET Education & Practice Online First, published on August 18, 2012 as 10.1136/archdischild-2012-302621 Copyright Article author (or their employer) 2012. Produced by BMJ Publishing Group Ltd under licence. group.bmj.com on June 18, 2017 Published by http://ep.bmj.com/ Downloaded from