Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial

Abstract

Background and objectives: In developed countries, where omphalitis has become rare and related mortality nil, benefits of antiseptic use in umbilical cord care have not been demonstrated. We aimed to assess the noninferiority of dry care compared with antiseptics in France where antiseptic use is widespread.

Methods: We conducted a noninferiority, cluster-randomized, 2-period crossover trial, in 6 French university maternity units including all infants born after 36 weeks' gestation. Maternity units were randomly assigned to provide either their usual antiseptic care or a dry care umbilical cord method for a 4-month period, and then units switched to the alternate cord cleansing method for a 4-month period. The primary outcome was neonatal omphalitis, adjudicated by an independent blinded committee based on all available photographs, clinical, and bacteriological data. We used a noninferiority margin of 0.4%. Analysis was performed per protocol and by intention to treat.

Results: Among 8698 participants, omphalitis occurred in 3 of 4293 (0.07%) newborns in the dry care group and in none of the 4404 newborns in the antiseptic care group (crude difference: 0.07; 95% confidence interval: -0.03 to 0.21). Late neonatal infection, parental appreciation of difficulty in care, and time to separation of the cord were not significantly different between the 2 groups.

Conclusions: Dry cord was noninferior to the use of antiseptics in preventing omphalitis in full-term newborns in a developed country. Antiseptic use in umbilical cord care is therefore unnecessary, constraining, and expensive in high-income countries and may be replaced by dry care.

Trial registration: ClinicalTrials.gov NCT01556867.