Clinical trial NCT03773289: Commonly Used Medicines On Neonatal Units in the UK
Official title: Drug Utilization Patterns in Neonatal Units in the UK: a Retrospective Pharmaco-epidemiological Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn
Pharmacoepidemiology
Intensive Care Units, Neonatal
Keywords: Infants, neonates
rational drug use
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 642729
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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).

Eligibility 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

Primary outcomes:
measure: Most commonly prescribed drugs in neonatal units in the UK
timeFrame: Last 8 years [01/01/2010 -31/12/2017]
measure: Change in pattern of drug use over 8 years in the UK
timeFrame: Last 8 years [01/01/2010 -31/12/2017]
Secondary outcomes:
measure: List of the most frequently used drugs by gestation category
timeFrame: Last 8 years [01/01/2010 -31/12/2017]
measure: Figures for the average duration of drug exposure by gestation category
timeFrame: Last 8 years [01/01/2010 -31/12/2017]
measure: List of the most frequently used drugs by care level of admitting neonatal unit
timeFrame: Last 8 years [01/01/2010 -31/12/2017]
measure: Figures for the average duration of drug exposure by birth weight
timeFrame: Last 8 years [01/01/2010 -31/12/2017]
Other outcomes:
Locations:
city: Derby
country: United Kingdom
facility: Division of Graduate Entry Medicine-School of Medicine
Study officials:
affiliation: University of Nottingham
name: Shalini Ojha, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Al-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.