NeoSep-ADAPT Qualitative Study
Research type
Research Study
Full title
Co-designing strategies to improve the design and delivery of complex trials within UK neonatal intensive care units (NICUs)
IRAS ID
341542
Contact name
Julia Bielicki
Contact email
Sponsor organisation
City St George's, University Of London, St George's School of Health and Medical Sciences
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Neonatal sepsis is a significant contributor to neonatal mortality and morbidity worldwide. Managing neonatal sepsis is a challenge, as presentation is often non-specific, lab test results are not always reliable, and determining appropriate antibiotic use, dosage, and duration in neonates requires further research.
Much of the gap between healthcare need and gold-standard evidence is related to the complexity of conducting neonatal trials. Adaptive platform trials may represent an important approach to address clinical management challenges in neonatal trials, allowing some flexibility around interventions given dependent on a pre-determined decision algorithm which assesses results in real-time and adjusts treatment arms in response. These trials could reduce time, cost, and number of participants required, arguably making trials more ethical.
However, further difficulties arise when implementing complex neonatal trials including recruitment and retention of participants, limited time for screening and consenting, ethical concerns around approaching parents during highly distressing periods, and the burden of research on healthcare staff. Qualitative research that explores the experiences of key stakeholders, including identifying both barriers and facilitators to participation in research, is therefore an essential component of trial development to ensure interventions are acceptable, feasible and sustainable.
Implementation science has not been widely applied to the context of clinical trials. In this study, the barriers to participation in neonatal research will be prospectively addressed by engaging with parents, healthcare staff, and neonatal trial teams through an implementation science lens. The project will include ethnographic research, semi-structured interviews, focus groups, and co-design workshops, prompting investigation of over-arching barriers to research participation and developing co-produced recommendations to address these. Creation of practical interventions, which can be embedded amongst routine clinical care, may aid implementation of complex neonatal infection trials in future.
This study is led by researchers at City St George’s, University of London. It is funded by NIHR.
REC name
South West - Frenchay Research Ethics Committee
REC reference
25/SW/0042
Date of REC Opinion
20 May 2025
REC opinion
Further Information Favourable Opinion