Many different antibiotics are used to treat infections in babies, although it is often unclear which to prescribe, as well as which dose and duration of treatment is most effective in this vulnerable patient group. It can be particularly difficult to choose antibiotics for neonatal sepsis, due to the urgency of the treatment and challenges with diagnosis. Additionally, a certain antibiotic, dose, or length of treatment could be problematic because the protective bacteria living in the baby’s gut may be altered or become resistant to antibiotics. There may also be long-term effects associated with antibiotic use in newborn babies, such as neurodevelopmental issues.
Research in this area is essential but difficult. The best way to study treatments is in a clinical trial, which is often challenging to carry out with newborn babies. Parents and healthcare staff find severe infections worrying and struggle to consider whether it is right for their baby to take part in research. Babies on NICU may have additional problems linked to prematurity or surgical conditions, so it is difficult to identify whether negative effects occur because of a treatment or the baby's pre-existing condition.
The NeoSep-ADAPT project aims to investigate the challenges associated with conducting research on severe neonatal infections, and co-design useful resources to address these clinical barriers in future trials on NICUs.
Parents and healthcare professionals with experience of NICUs in the UK will be included in interview and focus group studies, respectively, to understand what barriers and facilitators exist when implementing research, particularly in the context of neonatal infections. The research team will also conduct observations at UK-based NICUs to assess how research intersects with the clinical duties of healthcare professionals, and any issues that arise in the delivery of clinical trials on the unit.
In the latter stages of the project, a co-design approach will be taken to design resources which provide appropriate information about the trial and severe infections to parents and staff, as well as other tools identified as necessary that can be used by researchers. Appropriate theories and frameworks from the implementation and behavioural sciences will be employed from the start of the project to inform topic guides, qualitative framework analysis, and co-design of resources. The study team will work with charities, NHS partners and the Neonatal Operational Delivery Networks.
Patient and Public Involvement (PPI) will play a key role in the project, providing insight into public and staff perspectives which will allow our team to develop a protocol for an adaptive platform trial. The research team will engage regularly with parent support groups, charities and partner neonatal units. These groups will be approached to identify interested parent and staff representatives, who will be asked to review and streamline the protocol and corresponding interventions to ensure that outputs emulate a patient- and family-centred model for neonatal infection trials. Through scientific findings from qualitative research and PPI contributions from the relevant stakeholder groups, this project will build a guide for increasing family and staff engagement with complex neonatal infection trials.
This project will help parents, babies, and healthcare professionals dealing with severe infections. It involves research at St George's Hospital in South London, so project outputs will be available to healthcare staff and parents based on the unit in future. The results of the project will also contribute to future trial design by illustrating the perspectives and needs of stakeholders who deliver or participate in neonatal research.
The project was funded by an NIHR Advanced Fellowship and will be completed by April 2026.