Impact of umbilical cord cleansing with 4.0% chlorhexidine on time to cord separation among newborns in Southern Nepal: A cluster-randomized, community-based trial

OBJECTIVE. Within a community-based, cluster-randomized study of the effects of 4.0% chlorhexidine on omphalitis and mortality risk, we aimed to describe the distribution of times to separation and the impact of topical chlorhexidine treatment on cord-separation times. METHODS. Between November 2002 and March 2005, 15 123 infants were assigned randomly within communities in southern Nepal to receive 1 of the following 3 cord-care regimens: cleansing with 4.0% chlorhexidine, cleansing with soap and water, or dry cord care. In intervention clusters, field workers cleansed the cord in the home on days 1, 2, 3, 4, 6, 8, and 10 after birth. Newborns were monitored throughout the newborn period for signs of omphalitis, and the time to cord separation was noted. Separation times were compared across treatment groups. Cord infection risk and a range of infant and household characteristics were assessed for their relationships to separation time. RESULTS. The mean separation time was shorter in dry cord care (4.24 days) and soap/water (4.25 days) clusters than in chlorhexidine clusters (5.32 days; mean difference: 1.08 days). Cords of infants who received chlorhexidine were 3.6 times more likely to separate after 7 days. Separation time was not associated with omphalitis. Home-delivered topical antiseptics, facility-based birth, and birth attendant hand-washing were associated with greater likelihoods of cord separation after 7 days of age. CONCLUSIONS. In this setting, the umbilical cord separated more rapidly than observed in hospital-based studies, and the impact of chlorhexidine cleansing on separation times was negligible. Increased cord-separation time attributable to topical chlorhexidine treatment should not be considered a factor in decision-making in settings where the baseline risk of omphalitis is high and chlorhexidine might reduce infection and mortality risks significantly.