[Translated article] PROA-KIDDDs study protocol: Evaluation of antimicrobial use and appropriateness in pediatric and neonatal care in Spain.

Abstract

Objective: To analyze the use of antimicrobials in the pediatric and neonatal population at a national level in order to identify consumption patterns, assess treatment appropriateness, and detect potential areas for improvement in therapeutic management.

Method: We designed a retrospective, cross-sectional, multicenter observational study that included neonatal (<1 month) and pediatric (<15 years) inpatients with at least one active prescription of systemic antibacterials or antifungals. The study consists of two phases. The first phase involves the analysis of antimicrobial consumption through quarterly data collection, expressed as pediatric and neonatal defined daily doses (DDD) per 100 patient-days. A temporal trend analysis will be performed using segmented regression and calculation of the average quarterly percent change with 95% confidence intervals, identifying change points through the Monte Carlo permutation method. The second phase focuses on evaluating prescription appropriateness based on indication, antimicrobial selection, timing of administration, dose, frequency, route of administration, treatment duration, monitoring of efficacy and adverse effects, and documentation in the medical record. The review will be conducted by a hospital pharmacist and an infectious diseases specialist, with interobserver verification in 25% of cases. A sample size of 379 patients (270 pediatric and 109 neonatal) has been estimated for this phase. Differences between variables will be analyzed using Student's t-test, Mann-Whitney U test, Chi-squared test, or Fisher's exact test as appropriate. Inter-rater agreement will be assessed using Cohen's Kappa coefficient, and factors associated with differences in appropriateness will be analyzed through binary logistic regression and generalized lineal mixed models.

Discussion: This study will allow the identification of antimicrobial consumption patterns and the evaluation of prescription appropriateness in pediatric and neonatal populations, providing objective and comparable information across centers. The findings will help strengthen Antimicrobial Stewardship Programs, serve as a solid basis for future research, and support the development of targeted national strategies, ultimately improving patient safety and helping to curb the progression of antimicrobial resistance.