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Completed

NCT Number: NCT03773289

Commonly Used Medicines On Neonatal Units in the UK

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.

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Key information

Conditions

Infant, Newborn Intensive Care Units, Neonatal Pharmacoepidemiology

Age range

0 week–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Graduate Entry Medicine-School of Medicine

Derby, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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)

  2. 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]

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: COMMON

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 12, 2018
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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