Commonly Used Medicines On Neonatal Units in the UK

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03773289
Study type	Observational
Source	University of Nottingham
Contact
Status	Completed
Phase
Start date	April 20, 2018
Completion date	April 19, 2021

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Commonly Used Medicines On Neonatal Units in the UK — COMMON

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms