Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan

NCT00682006 ↗

Phase 3 Completed 9800 enrolled Aga Khan University John Snow, Inc. · collab

RandomizedFactorialOpen-labelPrevention

Summary

The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.

Timeline

Start: 2008-01
Primary completion: 2009-09
Completion: 2009-12

Outcome

Met primary endpoint

paper reduction in risk of omphalitis with CHX application (risk ratio [RR]=0·58, 95% CI 0·41-0·82; p=0·002) PMID 22322126 ↗

paper strong evidence of a reduction in neonatal mortality in neonates who received CHX cleansing (RR=0·62, 95 % CI 0·45-0·85; p=0·003) PMID 22322126 ↗

Publications

Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. 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 Mar 17;379(9820):1029-36. doi: 10.1016/S0140-6736(11)61877-1. Epub 2012 Feb 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chlorhexidine	Small molecule	4 %	Topical