Trial reportPloS one2018
Treatment with silver nitrate versus topical steroid treatment for umbilical granuloma: A non-inferiority randomized control trial.
Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 33 citations in OpenAlex.
- Clinical analysis of 25 cases of infant umbilical granuloma treated with topical application of common salt granules.Frontiers in pediatrics · 2025Article
- Umbilical Granuloma: Frequency, Associated Factors, 10-Year Treatment Trends, and Effectiveness at a Single Hospital in Japan.Journal of clinical medicine · 2023Article
- Umbilical granuloma frequency of newborns in Third-line Hospital in Turkey.African health sciences · 2022Article
- Small Bowel Injury Due to Electrocautery Excision of Umbilical Granuloma in a Four-Month-Old Child.Cureus · 2022Article
- The Outcome of Salt Treatment for Umbilical Granuloma: A Systematic Review.Patient preference and adherence · 2020Review
- Article
- Common Salt versus Silver Nitrate for the Treatment of Umbilical Granuloma in Infants: An Open-label, Single-center, Pilot Randomized Controlled Trial.Journal of Indian Association of Pediatric SurgeonsArticle
- Efficacy and Safety of Common Salt and other Topical Agents in the Treatment of Umbilical Granuloma in Neonates and Infants: A Systematic Review and Meta-analysis.Journal of Indian Association of Pediatric SurgeonsReview
Corrections and comments
- Erratum issued
Authors and funding
21 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.