Chlorhexidine cleansing of the umbilical cord and separation time: a cluster-randomized trial.

OBJECTIVE: Cord cleansing with chlorhexidine reduces neonatal mortality. We aimed to quantify the impact of this intervention on cord separation time and the implications of such an increase on maternal and other caretaker's acceptance of chlorhexidine in future scaled up programs.

METHODS: Between June 2007 and September 2009, 29,760 newborns were randomly assigned within communities in Bangladesh to receive 1 of 3 cord regimens: dry and clean cord care (comparison), single-cleansing, or multiple-cleansing with 4.0% chlorhexidine. Workers recorded separation status during home visits. Mothers of 380 infants in randomly selected clusters reported age at separation and satisfaction with cord regimen.

RESULTS: Compared with dry and clean care (mean 4.78 days), separation time was longer in the single (mean 6.90 days, difference = 2.10; 95% confidence interval: 1.85-2.35) and multiple (mean 7.49 days, difference = 2.69; 95% confidence interval: 2.44-2.95) cleansing groups. Increased separation time was not associated with omphalitis. Mothers in these groups more frequently reported "longer than usual" separation times and dissatisfaction with the separation time (11.1% and 17.6%, respectively) versus the comparison group (2.5%). Overall satisfaction with the received cord care regimen was high (96.2%).

CONCLUSIONS: Topical chlorhexidine increased cord separation time by ∼50%. Caretakers are likely to detect this increase and might express dissatisfaction but still accept the intervention overall. When scaling up chlorhexidine cord cleansing, inclusion of appropriate messaging on expectation and nonrisks of increased cord separation time, in addition to the benefits of reduced infection and improved survival, might improve compliance.