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Development and validation of a predictive tool for adverse drug reactions in neonates under intensive care.
Leopoldino, Ramon Weyler; Marques, Daniel Paiva; Rocha, Luan Carvalho; Medeiros Fernandes, Flávia Evelyn; Oliveira, Antonio Gouveia; Martins, Rand Randall.
Affiliation
  • Leopoldino RW; Graduate Program of Pharmaceutical Science, Health Science Center, Federal University of Rio Grande do Norte, Natal, Brazil.
  • Marques DP; Pharmacy Department, Health Science Center, Federal University of Rio Grande do Norte, Natal, Brazil.
  • Rocha LC; Pharmacy Department, Health Science Center, Federal University of Rio Grande do Norte, Natal, Brazil.
  • Medeiros Fernandes FE; School Maternity Januário Cicco (MEJC/EBSERH), Health Science Center, Federal University of Rio Grande do Norte, Natal, Brazil.
  • Oliveira AG; Graduate Program of Pharmaceutical Science, Health Science Center, Federal University of Rio Grande do Norte, Natal, Brazil.
  • Martins RR; Graduate Program of Pharmaceutical Science, Health Science Center, Federal University of Rio Grande do Norte, Natal, Brazil.
Br J Clin Pharmacol ; 90(3): 793-800, 2024 03.
Article in En | MEDLINE | ID: mdl-37926508
AIMS: Neonates hospitalized in neonatal intensive care units (NICUs) commonly experience adverse drug reactions (ADRs). 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 2019 to January 2022 [Correction added on 4 December 2023, after first online publication: 2023 has been changed to 2019 in the preceding sentence.]. Neonates with ADR were randomly paired with 2 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 curve with bootstrap adjusted c-statistics. RESULTS: In all, 450 neonates (150 cases and 300 controls) were included in the study. We identified 5 independent risk factors for ADR, 4 related to the neonate (current mechanical ventilation, heart rate ≥178 beats/min, intravenous medications, ≥5 prescription medications) and 1 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 receiver operating characteristic curve of 0.74 (95% confidence interval [CI] 0.66-0.81) with sensitivity of 52.02% (95% CI 47.40-56.64) and specificity of 81.35% (95% CI 77.75-84.95). CONCLUSION: The tool demonstrated adequate discriminative ability and utilized 5 commonly monitored variables in the NICU.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions Limits: Female / Humans / Newborn / Pregnancy Language: En Journal: Br J Clin Pharmacol Year: 2024 Type: Article Affiliation country: Brazil

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Drug-Related Side Effects and Adverse Reactions Limits: Female / Humans / Newborn / Pregnancy Language: En Journal: Br J Clin Pharmacol Year: 2024 Type: Article Affiliation country: Brazil