Chlorhexidine gel versus aqueous for preventive use on umbilical stump: A randomized noninferiority trial

Background: Recent trials of chlorhexidine cord cleansing have employed aqueous solution applied with cotton swabs. Care-takers may prefer gel, resulting in better compliance when implemented at large scale. We examined whether a guar-gum-thickened formulation was at least as efficacious as aqueous in reducing periumbilical flora. Methods: Newborns (n = 694) from normal deliveries at a hospital in Kathmandu were randomly allocated to cord cleansing with either gel or aqueous chlorhexidine, applied by finger. Immediately before and 24 hours after cleansing, periumbilical swabs were collected and cultured. The primary outcome was periumbilical colonization at 24 hours. Household-level acceptability and ease of use in a rural setting where most deliveries are not attended by health workers were assessed by providing 61 women with either gel or aqueous formulations and following up on their experience using the products. Results: Babies allocated to gel and aqueous chlorhexidine were comparable on a range of variables measured at baseline. At 24 hours postapplication, 4.6% (15 of 327) of cultures were positive in the gel group and 10.7% (35 of 326) in the aqueous group. The absolute difference in rates (gel minus aqueous) was -6.1% (95% CI: -10.2%, -2.1%). The acceptability study found that satisfaction and compliance were high for both; use of either largely displaced the traditional use of oil-based mixtures. Overall, there was a preference for gel. Conclusions: The gel formulation was not inferior to aqueous and gel reduced bacterial colonization to a greater degree. A gel formulation might be considered in future research or program settings where chlorhexidine cleansing of the cord is being evaluated or promoted.