Infant, NewbornCOMMONNCT03773289
Commonly Used Medicines On Neonatal Units in the UK
An observational study of Infant, Newborn and Pharmacoepidemiology, run by University of Nottingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 0 weeks to 6 months
- Conditions the study is for
- Infant, Newborn, Pharmacoepidemiology, Intensive Care Units, Neonatal
- How many people
- 642,729 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2018to 19 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Infants who received all their care in the postnatal ward
- Infants who were not admitted to any neonatal unit
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of Graduate Entry Medicine-School of Medicine
Derby
About this study
Official title: 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.
Read the 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).
- Being tested
- No intervention
- Keywords
- Infants, neonates, rational drug use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.
What is being measured
The primary outcome is the main question the study is designed to answer.
Most commonly prescribed drugs in neonatal units in the UK
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)
Measured: Last 8 years [01/01/2010 -31/12/2017]
Change in pattern of drug use over 8 years in the UK
listing the most frequently used drugs by year.
Measured: Last 8 years [01/01/2010 -31/12/2017]
Secondary outcomes (4)
List of the most frequently used drugs by gestation category
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)
Measured: Last 8 years [01/01/2010 -31/12/2017]
Figures for the average duration of drug exposure by gestation category
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]
Measured: Last 8 years [01/01/2010 -31/12/2017]
List of the most frequently used drugs by care level of admitting neonatal unit
The definition is (Level 3 Neonatal Intensive Care Units; Level 2 Local Neonatal Units)
Measured: Last 8 years [01/01/2010 -31/12/2017]
Figures for the average duration of drug exposure by birth weight
The birth weight is grouped in 250g increments from <500g to >2500g
Measured: Last 8 years [01/01/2010 -31/12/2017]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start20 Apr 2018
- Primary completion19 Apr 2020
- Study completion19 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 642,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shalini Ojha, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773289
- Sponsor's protocol ID
- 18023
- Acronym
- COMMON
- Status last verified
- Mar 2020
- First submitted
- 5 Dec 2018
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Turkait A, Szatkowski L, Choonara I, Ojha S. Management of patent ductus arteriosus in very preterm infants in England and Wales: a retrospective cohort study. BMJ Paediatr Open. 2022 Mar;6(1):e001424. doi: 10.1136/bmjpo-2022-001424.
PubMed 36053632Al-Turkait A, Szatkowski L, Choonara I, Ojha S. Drug utilisation in neonatal units in England and Wales: a national cohort study. Eur J Clin Pharmacol. 2022 Apr;78(4):669-677. doi: 10.1007/s00228-021-03267-x. Epub 2022 Jan 13.
PubMed 35028673
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Patterns in Neonatal Units in the UK: a Retrospective Pharmaco-epidemiological Study
- ClinicalTrials.gov ID
- NCT03773289
- Acronym / sponsor ID
- COMMON / 18023
- Keywords
- Infants, neonates, rational drug use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642,729 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 19 Apr 2020 (actual)
- Study completion
- 19 Apr 2021 (actual)
- First posted
- 12 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Infants who received all their care in the postnatal ward
- Infants who were not admitted to any neonatal unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention. | Other | – |
Primary outcome
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)
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.
4 secondary outcomes
List of the most frequently used drugs by gestation category
Time frame: 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]
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]
Figures for the average duration of drug exposure by birth weight
Time frame: Last 8 years [01/01/2010 -31/12/2017]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Derived from this study: PubMed 36053632Al-Turkait A, Szatkowski L, Choonara I, Ojha S. Management of patent ductus arteriosus in very preterm infants in England and Wales: a retrospective cohort study. BMJ Paediatr Open. 2022 Mar;6(1):e001424. doi: 10.1136/bmjpo-2022-001424.
- Derived from this study: PubMed 35028673Al-Turkait A, Szatkowski L, Choonara I, Ojha S. Drug utilisation in neonatal units in England and Wales: a national cohort study. Eur J Clin Pharmacol. 2022 Apr;78(4):669-677. doi: 10.1007/s00228-021-03267-x. Epub 2022 Jan 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Ojha, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Newborn and Pharmacoepidemiology, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Most commonly prescribed drugs in neonatal units in the UK (time frame: Last 8 years [01/01/2010 -31/12/2017]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773289, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.