Proton Pump Inhibitors in children
Abstract
[1]¿p#1 Aim To systematically evaluate the safety of PPI therapy in children aged 0 to 12 years, with a focus on treatment-emergent adverse events across different study designs and age groups. Method The systematic Review was carried out according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Literature search was conducted across multiple electronic databases, including PubMed, Embase, Cochrane Library, Scopus, Google Scholar and Grey literature sources, Eligible studies included Retrospective cohort study, Randomized Controlled Trials and Phase 1/ Early-Phase Studies. Data extraction focused on reported adverse events, patient age, drug type, and treatment duration. The methodological quality was assessed using study-design-specific tools. Randomized controlled trials were evaluated with the Cochrane Risk of Bias 2.0 (RoB 2) tool, observational cohort studies with the Newcastle-Ottawa Scale (NOS), and non-randomized interventional studies with the Methodological Index for Non-Randomized Studies (MINORS). Conclusion Short-term PPI use in children appears generally safe, with predominantly mild gastrointestinal and respiratory adverse events. Serious complications are uncommon but may be underestimated due to limited follow-up and inconsistent reporting. Use of PPIs in infants with physiological reflux is discouraged, as gastric contents are typically non-acidic due to milk buffering.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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