Neonatal adverse drug reactions
Abstract:
Aims: Neonates hospitalized in Neonatal Intensive Care Unit (NICU) commonly experience Adverse Drug Reactions (ADR). Thus, we aimed to develop and validate a tool for predicting ADRs in neonates hospitalized in NICUs.
Methods: A nested case-control study in an open cohort with neonates admitted to the NICU of a maternity hospital in Natal/Brazil was conducted from January 2023 to January 2022. Neonates with ADR were randomly paired with two controls. For the development of the tool, a multivariate logistic regression was applied on 2/3 of the sample (cases with respective controls). The model’s fit was evaluated using the Hosmer-Lemeshow test for calibration and the Brier score for performance assessment. Validation of the tool was performed by determining the area under the Receiver Operating Characteristic (ROC) curve with bootstrap adjusted c-statistics.
Results: In all, 450 neonates (150 cases and 300 controls) were included in the study. We identified five independent risk factors for ADR, four related to the neonate (current mechanical ventilation, heart rate ≥ 178 bpm, intravenous medications, five or more prescription medications) and one to the mother (gestational hypertension). The tool had a classification cut-off point of ≥15 and its total score ranged from 0 to 34. In validation, the tool had an area under the ROC curve of 0.74 (95%CI 0.66 – 0.81) with sensitivity of 52.02% (IC95% 47.40 – 56.64) and specificity of 81.35% (IC95% 77.75 – 84.95).
Conclusion: The tool demonstrated adequate discriminative ability and utilized five commonly monitored variables in the NICU.
Reference:
Duarte Leopoldino RW, Marques DP, Rocha LC, Medeiros Fernandes FE, Oliveira AG, Martins RR. Development and validation of a predictive tool for Adverse Drug Reactions in neonates under intensive care. Br J Clin Pharmacol. 2023 Nov 5. doi: 10.1111/bcp.15954. Epub ahead of print. PMID: 37926508.