Analysing the effects of a novel anti-inflammatory approach for currently untreatable diseases of the preterm baby using data from Anakinra Pilot, the first clinical trial of its kind

Early life inflammation causes severe diseases in babies born preterm, including the chronic lung disease bronchopulmonary dysplasia (BPD), the devastating disease necrotising enterocolitis (NEC) affecting the premature gut, and diffuse white matter injury of the brain, which itself often contributes to cerebral palsy in later life. No safe and effective therapy is available for any of these diseases, which cause great suffering in the babies and their families, as well as immense health care costs. Work done in our lab and others has revealed a key role for the pro-inflammatory cytokine interleukin (IL-)1. We therefore designed and conducted a clinical trial, Anakinra Pilot, to establish that it is safe to block IL-1-driven inflammation using IL-1 receptor antagonist (IL-1Ra; drug name anakinra), thus paving the way for the first targeted anti-inflammatory therapy for preterm babies. Anakinra Pilot finished recruiting early in 2024. We have collected a substantial number of extremely precious samples from blood, gut and lung from the baby participants, as well as from matched control babies. This project will analyse the effects of anakinra using the samples we have collected and state-of-the-art methods such as highly multiplexed flow cytometry, proteomics, multiplex ELISAs and biased and unbiased methods of the resulting big datasets. Immediate clinical relevance: High Involvement of students: As per above; flow cytometry, proteomics, multiplex ELISAs and biased as well as unbiased methods of analysis and flow cytometry and by analysis of selected biochemical markers.