Oral steroids for reducing kidney scarring in young children with febrile urinary tract infections: the contribution of Bayesian analysis to a randomized trial not reaching its intended sample size

Liviana Da Dalt, Silvia Bressan, Floriana Scozzola, Enrico Vidal, Monia Gennari, Claudio La Scola, Mauro Anselmi, Elisabetta Miorin, Pietro Zucchetta, Danila Azzolina, Dario Gregori, Giovanni Montini

Research output: Contribution to journalArticlepeer-review

Abstract

Background: This study aimed to evaluate the effect of oral dexamethasone in reducing kidney scars in infants with a first febrile urinary tract infection (UTI). Methods: Children aged between 2 and 24 months with their first presumed UTI, at high risk for kidney scarring based on procalcitonin levels (≥1 ng/mL), were randomly assigned to receive dexamethasone in addition to routine care or routine care only. Kidney scars were identified by kidney scan at 6 months after initial UTI. Projections of enrollment and follow-up completion showed that the intended sample size could not be reached before funding and time to complete the study ran out. An amendment to the protocol was approved to conduct a Bayesian analysis. Results: We randomized 48 children, of whom 42 had a UTI and 18 had outcome kidney scans (instead of 128 planned). Kidney scars were found in 0/7 and 2/11 patients in the treatment and control groups respectively. The probability that dexamethasone could prevent kidney scarring was 99% in the setting of an informative prior probability distribution (which fully incorporated in the final inference the information on treatment effect provided by previous studies) and 98% in the low-informative scenario (which discounted the prior literature information by 50%). The probabilities that dexamethasone could reduce kidney scar formation by up to 20% were 61% and 53% in the informative and low-informative scenario, respectively. Conclusions: Dexamethasone is highly likely to reduce kidney scarring, with a more than 50% probability to reduce kidney scars by up to 20%. Trial registration number: EudraCT number: 2013-000388-10; registered in 2013 (prospectively registered) Graphical Abstract: [Figure not available: see fulltext.]

Original languageEnglish
Pages (from-to)3681-3692
JournalPediatric Nephrology
Volume36
Issue number11
DOIs
Publication statusPublished - 2021

Keywords

  • Children
  • Dexamethasone
  • Kidney scars
  • Pyelonephritis
  • Urinary tract infections

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Nephrology

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