Tunbridge Wells

Researchers are evaluating the safety and effectiveness of whole-body hypothermia for newborn babies with mild hypoxic ischaemic encephalopathy. This phase III randomised controlled trial aims to determine whether cooling the whole body to 33.5.5C within six hours after birth and continuing for 72 hours improves cognitive development at around two years of age compared with maintaining normal body temperature. The study also seeks to assess the economic value of cooling therapy for mild encephalopathy within the healthcare system. Babies born at or after 36 weeks with signs of birth asphyxia or acidosis will be randomly assigned to receive either whole-body hypothermia or targeted normothermia. Cooling will be applied using a servo-controlled machine in neonatal intensive care units, maintaining a rectal temperature of about 33.5C for 72 hours. The control group will have their body temperature kept at normal levels 37C for the first 80 hours, with any fever carefully treated. Babies born at non-cooling centers will be transferred to specialized units for treatment. During the study, participants will undergo brain monitoring, MRI scans before discharge, and follow-up developmental assessments at 24 months using the Bayley Scales of Infant and Toddler Development IV. Additional evaluations will include neurological exams, motor function assessments, vision and hearing tests, and parent-completed questionnaires. Researchers will collect detailed clinical data from birth through hospital stay, aiming to compare cognitive outcomes and safety measures between the two groups over the study period.

Developmental Dysplasia of the Hip DDH is a common condition in infants that can lead to disability if not treated properly. This research aims to find out whether babies with stable but immature Graf type 2b and 2c hips need treatment with a Pavlik harness or if their hips can mature naturally without it. The study is a feasibility trial conducted to compare the outcomes of babies treated with the harness versus those who are closely monitored without initial treatment. Babies in the study will be randomly assigned to one of two groups. One group will receive the usual care involving a Pavlik harness worn 24 hours a day for up to 12 weeks, with ultrasound scans at 3, 8, and 12 weeks after treatment begins. The other group will be under watchful waiting, having ultrasound scans every 3 weeks at 3, 6, 9, and 12 weeks to monitor hip maturation. If hips in the monitoring group do not mature, babies will be switched to harness treatment. Both groups will have X-rays taken at 9 and 15 months to assess long-term hip development. Participants will undergo baseline assessments including ultrasound and physical exams, and parents will complete stress questionnaires at various points. The harness group will have regular checks to ensure proper fit and monitor skin and nerve health. Parents in both groups will have access to support and emergency contact. The study will last 15 months per participant, with data collected on hip development, parent stress, and treatment outcomes to help determine if harness treatment is necessary for stable, immature hips.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.