<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03773289</url>
  </required_header>
  <id_info>
    <org_study_id>18023</org_study_id>
    <nct_id>NCT03773289</nct_id>
  </id_info>
  <brief_title>Commonly Used Medicines On Neonatal Units in the UK</brief_title>
  <acronym>COMMON</acronym>
  <official_title>Drug Utilization Patterns in Neonatal Units in the UK: a Retrospective Pharmaco-epidemiological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This retrospective analysis of drug utilisation data aims to study the patterns of use of&#xD;
      medicines in neonatal units in the UK from 2010 to 2017. Prescribing drugs in neonates can be&#xD;
      complex and the application of pharmacotherapy principles can be challenging due to the lack&#xD;
      of licenced formulations and limited evidence-base for indications, dosing and/or adverse&#xD;
      events. A systematic review of drug utilisation pattern in neonatal units in different health&#xD;
      care settings identified antibiotics, caffeine and vitamin supplements as the most commonly&#xD;
      used drugs and highlighted that further research is needed to investigate drug utilisation&#xD;
      and rational use of medicines in neonates. The only UK study included in this systematic&#xD;
      review and available from our search of literature was conducted in 2009. This survey,&#xD;
      however, had a low response rate (only 42% units responded) and it included data collection&#xD;
      over a very short period of 2 weeks and that could limit its generalisability to other NICU&#xD;
      settings. It identified the need for research in to medicines for neonates and that this&#xD;
      research agenda should be informed by the extent of medication use in this field. However,&#xD;
      our literature search revealed that there is very little information on the current patterns&#xD;
      of medication use in neonates. An updated drug utilisation study is warranted in a neonatal&#xD;
      setting in UK.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to investigate current and recent patterns of drug utilisation in&#xD;
      neonatal units in the UK.&#xD;
&#xD;
      We will conduct a retrospective pharmacoepidemiological study of a large prospectively&#xD;
      collected database (The National Neonatal Research Database -REC Number 16/LO/1093). The&#xD;
      study will use de-identified historical data recorded in this database. There is no patient&#xD;
      recruitment and the project involves no changes to patient care. The data to be used for this&#xD;
      project are stored in de-identified form.&#xD;
&#xD;
      Data items will include descriptive, background data to allow for age and gestation at the&#xD;
      time of drug use and subgroup analysis (such as birth weight, gestational age, clinical&#xD;
      condition, day of drug use) and data on drug use (name of drug and age at use).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 20, 2018</start_date>
  <completion_date type="Actual">April 19, 2021</completion_date>
  <primary_completion_date type="Actual">April 19, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Most commonly prescribed drugs in neonatal units in the UK</measure>
    <time_frame>Last 8 years [01/01/2010 -31/12/2017]</time_frame>
    <description>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)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pattern of drug use over 8 years in the UK</measure>
    <time_frame>Last 8 years [01/01/2010 -31/12/2017]</time_frame>
    <description>listing the most frequently used drugs by year.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>List of the most frequently used drugs by gestation category</measure>
    <time_frame>Last 8 years [01/01/2010 -31/12/2017]</time_frame>
    <description>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 &lt; 28 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Figures for the average duration of drug exposure by gestation category</measure>
    <time_frame>Last 8 years [01/01/2010 -31/12/2017]</time_frame>
    <description>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 &lt; 28 weeks]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>List of the most frequently used drugs by care level of admitting neonatal unit</measure>
    <time_frame>Last 8 years [01/01/2010 -31/12/2017]</time_frame>
    <description>The definition is (Level 3 Neonatal Intensive Care Units; Level 2 Local Neonatal Units)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Figures for the average duration of drug exposure by birth weight</measure>
    <time_frame>Last 8 years [01/01/2010 -31/12/2017]</time_frame>
    <description>The birth weight is grouped in 250g increments from &lt;500g to &gt;2500g</description>
  </secondary_outcome>
  <enrollment type="Actual">642729</enrollment>
  <condition>Infant, Newborn</condition>
  <condition>Pharmacoepidemiology</condition>
  <condition>Intensive Care Units, Neonatal</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Infants admitted to neonatal units in England, Scotland, and Wales&#xD;
&#xD;
          -  Admitted between 01 January 2010 and 31 December 2017.&#xD;
&#xD;
          -  No limits in gestational age or birth weight.&#xD;
&#xD;
        Exclusion cirteria&#xD;
&#xD;
          -  Infants who received all their care in the postnatal ward&#xD;
&#xD;
          -  Infants who were not admitted to any neonatal unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  Infants admitted to neonatal units in England, Scotland, and Wales&#xD;
&#xD;
          -  Admitted between 01 January 2010 and 31 December 2017.&#xD;
&#xD;
          -  No limits in gestational age or birth weight.&#xD;
&#xD;
        Exclusion cirteria&#xD;
&#xD;
          -  Infants who received all their care in the postnatal ward&#xD;
&#xD;
          -  Infants who were not admitted to any neonatal unit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Weeks</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shalini Ojha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Graduate Entry Medicine-School of Medicine</name>
      <address>
        <city>Derby</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infants, neonates</keyword>
  <keyword>rational drug use</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03773289
org study id: 18023
nct id: NCT03773289
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
observational model: Cohort
time perspective: Retrospective
measure: Most commonly prescribed drugs in neonatal units in the UK
time frame: Last 8 years [01/01/2010 -31/12/2017]
description: 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)
measure: Change in pattern of drug use over 8 years in the UK
time frame: Last 8 years [01/01/2010 -31/12/2017]
description: listing the most frequently used drugs by year.
measure: List of the most frequently used drugs by gestation category
time frame: Last 8 years [01/01/2010 -31/12/2017]
description: 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)
measure: Figures for the average duration of drug exposure by gestation category
time frame: Last 8 years [01/01/2010 -31/12/2017]
description: 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]
measure: 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]
description: The definition is (Level 3 Neonatal Intensive Care Units; Level 2 Local Neonatal Units)
measure: Figures for the average duration of drug exposure by birth weight
time frame: Last 8 years [01/01/2010 -31/12/2017]
description: The birth weight is grouped in 250g increments from <500g to >2500g
intervention type: Other
intervention name: No intervention
description: This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 0 Weeks
maximum age: 6 Months
healthy volunteers: No
last name: Shalini Ojha, PhD
role: Principal Investigator
affiliation: University of Nottingham
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No