Commonly Used Medicines On Neonatal Units in the UK

NCT03773289 | Completed

• 1 other identifier: 18023
• Study Type: observational
• Target: 642,729
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Newborn; Pharmacoepidemiology; Intensive Care Units, Neonatal

Keywords

Infants, neonates; rational drug use

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  Last 8 years [01/01/2010 -31/12/2017]

Secondary Outcomes (4)

• List of the most frequently used drugs by gestation category

  Last 8 years [01/01/2010 -31/12/2017]

• Figures for the average duration of drug exposure by gestation category

  Last 8 years [01/01/2010 -31/12/2017]

• List of the most frequently used drugs by care level of admitting neonatal unit

  Last 8 years [01/01/2010 -31/12/2017]

• Figures for the average duration of drug exposure by birth weight

  Last 8 years [01/01/2010 -31/12/2017]

Interventions

No intervention OTHER

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

Eligibility Criteria

• Age: 0 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.
• Infants who received all their care in the postnatal ward
• Infants who were not admitted to any neonatal unit

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Division of Graduate Entry Medicine-School of Medicine

Derby, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 36053632 DERIVED

• 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.

  PMID: 35028673 DERIVED

Study Officials

• Shalini Ojha, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 12, 2018
• Study Start: April 20, 2018
• Primary Completion: April 19, 2020
• Study Completion: April 19, 2021
• Last Updated: April 28, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)