Abstract
ObjectiveThe aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma.MethodsAn open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The healing rate was evaluated until completion of 3 weeks of treatment.ResultsParticipants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104) or topical steroid ointment (n = 103). Healing rates after 2 weeks of treatment were 87.5% (91/104) in the silver nitrate cauterization and 82% (82/100) in the topical steroid ointment group group. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%), indicating that the non-inferiority criterion was not met. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 [90.4%] vs. 91/100 [91.0%]; 0.6% [-13.2 to 14.3]). No major complications occurred in either group.ConclusionsThis study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. To clarify non-inferiority, a larger study is needed.
Highlights
Umbilical granuloma (UG) is the most common umbilical abnormality in neonates
Considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity
In the Topical steroid ointment (TSO) group, 3 patients changed to silver nitrate cauterization (SNC) treatment, with one achieving cure after 3 weeks of treatment, and another after 4 weeks, while the remaining patient underwent ligation after 3 weeks and achieved cure after 4 weeks of treatment. This prospective, nonblinded, multicenter randomized controlled trial (RCT) compared the efficacies of SNC and TSO treatments in neonates with newly diagnosed UG
Summary
The most commonly used treatment for UG is silver nitrate cauterization (SNC) [1, 2]. Various studies have investigated alternatives to SNC, including common salt [7], cryosurgery or electrocautery [8], excision and application of absorbable hemostatic materials [9], double ligatures [10], and alcoholic wipes [5]. Topical steroid ointment (TSO) treatment for UG has gained wide attention due to the advantages of effectiveness and simplicity [11, 12]. Brodsgaard et al raised the possibility that topical clobetasol propionate (0.05%), as a group IV steroid, may be as effective as SNC for treatment of UG [11]. That study was not large enough to show superiority or non-inferiority to SNC
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