Commonly Used Medicines On Neonatal Units in the UK (COMMON)

April 27, 2021 updated by: University of Nottingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

642729

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Derby, United Kingdom
        • Division of Graduate Entry Medicine-School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusion criteria

  • Infants admitted to neonatal units in England, Scotland, and Wales
  • Admitted between 01 January 2010 and 31 December 2017.
  • No limits in gestational age or birth weight.

Exclusion cirteria

  • Infants who received all their care in the postnatal ward
  • Infants who were not admitted to any neonatal unit

Description

Inclusion criteria

  • Infants admitted to neonatal units in England, Scotland, and Wales
  • Admitted between 01 January 2010 and 31 December 2017.
  • No limits in gestational age or birth weight.

Exclusion cirteria

  • Infants who received all their care in the postnatal ward
  • Infants who were not admitted to any neonatal unit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Most commonly prescribed drugs in neonatal units in the UK
Time Frame: Last 8 years [01/01/2010 -31/12/2017]
List the most commonly prescribed drugs in neonatal units in the UK (proportion of all infants exposed to each drug at least once during their admission)
Last 8 years [01/01/2010 -31/12/2017]
Change in pattern of drug use over 8 years in the UK
Time Frame: Last 8 years [01/01/2010 -31/12/2017]
listing the most frequently used drugs by year.
Last 8 years [01/01/2010 -31/12/2017]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
List of the most frequently used drugs by gestation category
Time Frame: Last 8 years [01/01/2010 -31/12/2017]
gestational category according to WHO definition (term: more than or equal to 37 weeks, moderate to late 32-36 weeks, very preterm 28-31 weeks, extremely preterm < 28 weeks)
Last 8 years [01/01/2010 -31/12/2017]
Figures for the average duration of drug exposure by gestation category
Time Frame: Last 8 years [01/01/2010 -31/12/2017]
gestational category according to WHO definition[term: more than or equal to 37 weeks, moderate to late 32-36 weeks, very preterm 28-31 weeks, extremely preterm < 28 weeks]
Last 8 years [01/01/2010 -31/12/2017]
List of the most frequently used drugs by care level of admitting neonatal unit
Time Frame: Last 8 years [01/01/2010 -31/12/2017]
The definition is (Level 3 Neonatal Intensive Care Units; Level 2 Local Neonatal Units)
Last 8 years [01/01/2010 -31/12/2017]
Figures for the average duration of drug exposure by birth weight
Time Frame: Last 8 years [01/01/2010 -31/12/2017]
The birth weight is grouped in 250g increments from <500g to >2500g
Last 8 years [01/01/2010 -31/12/2017]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Shalini Ojha, PhD, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2018

Primary Completion (ACTUAL)

April 19, 2020

Study Completion (ACTUAL)

April 19, 2021

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 11, 2018

First Posted (ACTUAL)

December 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 18023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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