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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773289
Recruitment Status : Active, not recruiting
First Posted : December 12, 2018
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Brief 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.

Condition or disease Intervention/treatment
Infant, Newborn Pharmacoepidemiology Intensive Care Units, Neonatal Other: No intervention

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).

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Study Type : Observational
Actual Enrollment : 642729 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Drug Utilization Patterns in Neonatal Units in the UK: a Retrospective Pharmaco-epidemiological Study
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 19, 2020
Estimated Study Completion Date : April 19, 2020

Intervention Details:
  • Other: No intervention
    This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773289


Locations
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United Kingdom
Division of Graduate Entry Medicine-School of Medicine
Derby, United Kingdom
Sponsors and Collaborators
University of Nottingham
Investigators
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Principal Investigator: Shalini Ojha, PhD University of Nottingham
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Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03773289    
Other Study ID Numbers: 18023
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Nottingham:
Infants, neonates
rational drug use