1. In this cluster-randomized, 2-period crossover trial, omphalitis occurred in 0.07% of newborns randomized to dry umbilical cord care compared to 0% in those using antiseptic care, demonstrating non-inferiority of dry cord care.
2. Secondary outcomes such as late neonatal infection, parental appreciation of difficulty in care, and time to separation of the cord did not significantly differ between the 2 groups.
Study Rundown: Omphalitis, infection of the umbilical cord stump, is a rare, yet serious complication among newborns in developed countries. It is unclear if “antiseptic cord care,” a practice in many developed countries, is necessary when “dry cord care” is a less expensive and simpler option. This study assessed the potential associated between cord care strategies and omphalitis development in multiple university-based hospitals in France, using a cluster-randomized 2-period crossover design with a 3-month washout period. Infants were randomized to receive standard of care (antiseptic-based cord care) and dry cord care involving cleansing with soap and water, followed by careful drying. Antiseptic care included the use of each maternity ward’s usual routine, typically 1-3 daily applications of an antiseptic solution. Overall, there were no cases of omphalitis in the antiseptic group and 3 cases in the dry care group, demonstrating non-inferiority of dry cord care in preventing omphalitis. The findings in this study support the implementation of dry cord care as a resource-saving measure that delivers the same level of care among infants born in developed countries. While informative, the generalizability of this study is limited to healthy term newborns and results cannot be applied to preterm infants or those in the intensive care unit setting. In addition, results may not be applicable to developing countries, where rates of omphalitis are exceedingly higher.
In-Depth [crossover trial]: This study included 8120 infants in maternity units in 6 different university-based hospitals in France. Two, 4-month study periods were separated by a 3-month wash out period in this cluster-randomized, 2-period crossover trial. In the control period, cord care was performed using standard antiseptic technique practice unique to each hospital. In the dry care period, the cord was cleansed with non-antiseptic soap and water, then gently dried. Caregivers were educated on the dry care technique both before and during the study period. Providers in the vicinity were notified of the study and asked to document and report suspected cases of omphalitis. An independent, blinded committee of 1 pediatrician, 1 dermatologist, and 1 pediatric surgeon evaluated the cases. Overall, there were 3 cases of omphalitis, with a risk difference of 0.07 (95% CI -0.03% to 0.21%) between the 2 groups. This value was well within the defined non-inferiority margin of 0.4%. Secondary outcomes included time to separation of the cord, parental satisfaction regarding umbilical cord care and healing, and late onset neonatal infection. There was no statistically significant difference between the 2 groups in any of these categories.
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