Adverse Drug Reactions in Neonates: ADRIN 1 methodology version 6.0
Research type
Research Study
Full title
Adverse Drug Reactions in Neonates 1: What are the best ways to evaluate suspected adverse drug reactions in neonates?
IRAS ID
215968
Contact name
Eve K Roberts
Contact email
Sponsor organisation
Health and Life Sciences University of Liverpool Research Support Office
Duration of Study in the UK
0 years, 9 months, 4 days
Research summary
Every year over 90,000 babies are treated in neonatal care units across the UK, and many babies will receive medicines, in both the wider community and inpatient care. Traditionally children and especially neonates have not been included in clinical trials of medicines due to ethical concerns (which are now seen to be misplaced). This means that there is incomplete knowledge about the benefits and harms of many medicines used in babies. It is important to monitor the adverse effects (side effects) of medicines given to babies.
This study aims to consider how we can improve the reporting and evaluation of adverse effects of medicines in the neonatal population by observing the effects of medicines prescribed to babies in a 54 bed neonatal unit over a 9 month period. This study will observe all babies admitted to the unit including those born prematurely until 28 days after they were due to be born. Information gathered from this work will be used to test several tools that currently exist to evaluate adverse effects of medicines. These tools have not been validated for use in the neonatal population so this study aims to analyse which tools may be appropriate for future use in the neonatal population.
REC name
Wales REC 7
REC reference
16/WA/0379
Date of REC Opinion
7 Dec 2016
REC opinion
Favourable Opinion