TY - JOUR
T1 - Topical applications of chlorhexidine to the umbilical cord for prevention of omphalitis and neonatal mortality in southern Nepal
T2 - A community-based, cluster-randomised trial
AU - Mullany, Luke C.
AU - Darmstadt, Gary L.
AU - Khatry, Subarna K.
AU - Katz, Joanne
AU - Leclerq, Steven C.
AU - Shrestha, Shardaram
AU - Adhikari, Ramesh
AU - Tielsch, James M.
N1 - Funding Information:
All members of the Nepal Nutrition Intervention Project, Sarlahi (NNIPS) collaborated on the successful implementation of this research project. Commodity support (perfume for masking intervention groups) was provided by Procter and Gamble Company, Cincinnati, Ohio. We thank the Data and Safety Monitoring Board members, P S S Sundar Rao, Pushpa Sharma, Dharma Manandhar, and Martin Bloem. This study was supported by grants from the National Institutes of Health, National Institute of Child Health and Human Development (HD44004 and HD38753), The Bill & Melinda Gates Foundation (810-2054), and cooperative agreements between the Johns Hopkins Bloomberg School of Public Health and the Office of Heath and Nutrition, United States Agency for International Development (HRN-A-00-97-00015-00, GHS-A-00-03-000019-00). These data were presented at the XVII IEA World Congress of Epidemiology, Bangkok, Thailand, August, 2005 and the 43rd Annual Meeting of the Infectious Diseases Society of America, San Francisco, USA, October, 2005.
PY - 2006/3/18
Y1 - 2006/3/18
N2 - Background: Omphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated. Methods: In our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4·0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1-4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with Clinicaltrials.gov, number NCT00109616. Findings: Frequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0·25, 95% CI 0·12-0·53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0·76 [95% CI 0·55-1·04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0·66 [0·46-0·95]). Soap and water did not reduce infection or mortality risk. Interpretation: Recommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality.
AB - Background: Omphalitis contributes to neonatal morbidity and mortality in developing countries. Umbilical cord cleansing with antiseptics might reduce infection and mortality risk, but has not been rigorously investigated. Methods: In our community-based, cluster-randomised trial, 413 communities in Sarlahi, Nepal, were randomly assigned to one of three cord-care regimens. 4934 infants were assigned to 4·0% chlorhexidine, 5107 to cleansing with soap and water, and 5082 to dry cord care. In intervention clusters, the newborn cord was cleansed in the home on days 1-4, 6, 8, and 10. In all clusters, the cord was examined for signs of infection (pus, redness, or swelling) on these visits and in follow-up visits on days 12, 14, 21, and 28. Incidence of omphalitis was defined under three sign-based algorithms, with increasing severity. Infant vital status was recorded for 28 completed days. The primary outcomes were incidence of neonatal omphalitis and neonatal mortality. Analysis was by intention-to-treat. This trial is registered with Clinicaltrials.gov, number NCT00109616. Findings: Frequency of omphalitis by all three definitions was reduced significantly in the chlorhexidine group. Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0·25, 95% CI 0·12-0·53; 13 infections/4839 neonatal periods) compared with dry cord-care clusters (52/4930). Neonatal mortality was 24% lower in the chlorhexidine group (relative risk 0·76 [95% CI 0·55-1·04]) than in the dry cord care group. In infants enrolled within the first 24 h, mortality was significantly reduced by 34% in the chlorhexidine group (0·66 [0·46-0·95]). Soap and water did not reduce infection or mortality risk. Interpretation: Recommendations for dry cord care should be reconsidered on the basis of these findings that early antisepsis with chlorhexidine of the umbilical cord reduces local cord infections and overall neonatal mortality.
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U2 - 10.1016/S0140-6736(06)68381-5
DO - 10.1016/S0140-6736(06)68381-5
M3 - Article
C2 - 16546539
AN - SCOPUS:33644994477
SN - 0140-6736
VL - 367
SP - 910
EP - 918
JO - Lancet
JF - Lancet
IS - 9514
ER -