Objective: to assess whether keeping the umbilical cord (UC) dry and clean is not inferior to the use of antiseptics to prevent omphalitis in newborns.
Design: noninferiority, cluster-randomized, 2-period crossover and unmasked study.
Setting: maternity units at 6 university hospitals in France.
Study population: the study included 8698 newborns (NBs) of more than 36 weeks’ gestational age; 293 were lost to followup (3.4%). Exclusion criteria: serious congenital malformation, admission to Intensive Care Unit, and families with anticipated barriers to adherence.
Intervention: children were clustered by maternity ward and time period and randomly assigned to the two different groups in a crossover design with two study periods of 4 months’ duration (3 months of treatment and 1 of followup), separated by a 3-month washout period. During the antiseptic care period (intervention group [IG]), the stump was cleaned one to three times a day with an antiseptic solution (alcohol with chlorhexidine, 70% alcohol or chlorhexidine solution). During the dry care period (control group [CG]), the stump was washed with water and nonantiseptic liquid soap and then carefully dried twice a day. The IG consisted of 4404 NBs and the CG of 4294 NBs. Both health care staff and the parents of NBs received written information on the correct cleaning procedure. Parents were encouraged to make an appointment if there were any abnormalities in the cord stump in the first 28 days, after which the researchers contacted the families by phone.
Outcome measures: the primary outcome was the development of omphalitis in the first 28 days of life, defined as purulent or malodorous discharge from the umbilical stump, periumbilical erythema, oedema or tenderness in the region. When suspected, NBs were assessed by other paediatricians. Other outcome variables included: time elapsed to separation of cord, parental satisfaction, hospital admission and development of infection and antibiotic therapy in the first 28 days of life. The authors assumed a proportion of omphalitis of 0.2% and established a noninferiority margin of 0.4%.
Main results: there were three cases of omphalitis in children that received dry care (0.07%) and none in children treated with antiseptics. The crude risk difference (RD) in the antiseptic group was 0.07% in the intention-to-treat analysis, with a 95% confidence interval (CI) of –0.03% to 0.21%. Medical visits for umbilical cord problems were more frequent in the CG, although the adjusted risk difference (ARD) of 0.72 (95 CI, –0.01 to 1.45; P = .052) was not statistically significant. There were no statistically significant differences in any of the other variables, either.
Conclusion: in developed countries, the use of antiseptics compared to keeping the umbilical stump dry and clean in term NBs is not only more costly, but also is not superior in preventing omphalitis. Thus, antiseptic care could be replaced by dry care.
Conflicts of interest: none disclosed.
Funding source: funded by a French research grant.