NCT03773289

Commonly Used Medicines On Neonatal Units in the UK

Drug Utilization Patterns in Neonatal Units in the UK: a Retrospective Pharmaco-epidemiological Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 642,729 (actual)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 0 Weeks – 6 Months
• Healthy volunteers: Not accepted

Summary

This retrospective analysis of drug utilisation data aims to study the patterns of use of medicines in neonatal units in the UK from 2010 to 2017. Prescribing drugs in neonates can be complex and the application of pharmacotherapy principles can be challenging due to the lack of licenced formulations and limited evidence-base for indications, dosing and/or adverse events. A systematic review of drug utilisation pattern in neonatal units in different health care settings identified antibiotics, caffeine and vitamin supplements as the most commonly used drugs and highlighted that further research is needed to investigate drug utilisation and rational use of medicines in neonates. The only UK study included in this systematic review and available from our search of literature was conducted in 2009. This survey, however, had a low response rate (only 42% units responded) and it included data collection over a very short period of 2 weeks and that could limit its generalisability to other NICU settings. It identified the need for research in to medicines for neonates and that this research agenda should be informed by the extent of medication use in this field. However, our literature search revealed that there is very little information on the current patterns of medication use in neonates. An updated drug utilisation study is warranted in a neonatal setting in UK.

Detailed description

The aim of this study is to investigate current and recent patterns of drug utilisation in neonatal units in the UK. We will conduct a retrospective pharmacoepidemiological study of a large prospectively collected database (The National Neonatal Research Database -REC Number 16/LO/1093). The study will use de-identified historical data recorded in this database. There is no patient recruitment and the project involves no changes to patient care. The data to be used for this project are stored in de-identified form. Data items will include descriptive, background data to allow for age and gestation at the time of drug use and subgroup analysis (such as birth weight, gestational age, clinical condition, day of drug use) and data on drug use (name of drug and age at use).

Conditions

• Infant, Newborn
• Pharmacoepidemiology
• Intensive Care Units, Neonatal

Interventions

Type	Name	Description
OTHER	No intervention	This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.

Timeline

• Start date: 2018-04-20
• Primary completion: 2020-04-19
• Completion: 2021-04-19
• First posted: 2018-12-12
• Last updated: 2021-04-28

Locations

1 site across 1 country: United Kingdom