Temporal profile of adverse drug reactions and associated clinical factors: a prospective observational study in a neonatal intensive care unit.

ABSTRACT:

Objective

Although adverse drug reactions (ADRs) are quite common in hospitalised neonates, pharmacovigilance activities in this public are still incipient. This study aims to characterise ADRs in neonates in a neonatal intensive care unit (NICU), identifying causative drugs, temporal profile and associated factors.

Design

Prospective observational study.

Setting

NICU of a public maternity hospital in Natal/Brazil.

Participants

All neonates admitted to the NICU for more than 24 hours and using at least one medication were followed up during the time of hospitalisation.

Primary outcome measures

Incidence rate and risk factors for ADRs. The ADRs were detected by an active search in electronic medical records and analysis of spontaneous reports in the hospi

SUBMITTER: Leopoldino RWD 

PROVIDER: S-EPMC10414078 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature