Whiston

Researchers are evaluating the safety and effectiveness of whole-body hypothermia treatment in newborn babies diagnosed with mild hypoxic ischaemic encephalopathy (HIE). This phase III randomized controlled trial aims to determine whether cooling babies to 33.57b0C within six hours of birth for 72 hours improves cognitive development at two years of age compared to maintaining normal body temperature (normothermia). The study also assesses the cost-effectiveness of cooling therapy to help guide national and international treatment guidelines and standardize care across the NHS. Babies born at or after 36 weeks with specific signs of birth asphyxia or acidosis are randomly assigned to either whole-body hypothermia or targeted normothermia groups. The hypothermia group will have their body temperature lowered and maintained at 33.57b0C using a cooling machine for 72 hours in a neonatal intensive care unit. The normothermia group will have their temperature maintained at 377b0C with treatment for any fever using standard protocols. If babies in the normothermia group develop seizures and worsen to moderate HIE, they may receive cooling treatment as part of clinical care. Conventional MRI scans will be performed before discharge. Participants will be followed up at 24 months of age (7 months) using the Bayley Scales of Infant and Toddler Development IV to measure cognitive, language, and motor skills. Additional neurological exams, including assessments for cerebral palsy, vision, and hearing, will be conducted. Parents will complete questionnaires about their child's development. Researchers will collect detailed clinical data from birth through follow-up to evaluate safety and developmental outcomes. Babies who die or cannot complete assessments due to severe disability will be assigned specific scores to reflect outcomes.

Researchers are evaluating the effectiveness and safety of infliximab, a drug that blocks tumor necrosis factor alpha (TNF-α), in treating acute pancreatitis (AP) in adults. AP is a severe inflammation of the pancreas causing intense pain and systemic issues that can lead to organ failure. The trial aims to determine if early anti-TNF treatment can reduce inflammation and improve outcomes in AP using a randomized, double-blind, placebo-controlled design in a Phase IIb study across multiple centers. Participants will be randomly assigned to one of three groups: one receiving a single intravenous infusion of infliximab at 5 mg/kg, another receiving infliximab at 10 mg/kg, and the last group receiving a placebo infusion of sodium chloride. The infliximab is administered via infusion to ensure rapid availability. The study evaluates the effects of these treatments on the inflammatory response in AP. During the study, researchers will monitor participants' serum C-reactive protein (CRP) levels on days 2, 4, and 14 to measure inflammation. Participants will undergo assessments including clinical evaluations, laboratory tests, and imaging as needed. Safety and treatment effects will be closely observed throughout the trial, which includes preparation and administration of the infusion within 36 hours of hospital admission. The study involves adult patients aged 18 to 85 years with a new diagnosis of AP, and participation includes obtaining consent and close monitoring during the treatment period.

Chronic obstructive pulmonary disease (COPD) is a common lung condition affecting about 10% of adults worldwide, with a prevalence of 4.5% in those aged 40 years and older in the UK. Exacerbations, or sudden worsening episodes often triggered by infections, can lead to hospital admissions and carry risks of increased illness and death. This trial focuses on the high-risk 90-day period after hospital discharge, during which patients have a 43% chance of readmission and 12% risk of mortality. The study aims to test whether a supported rescue pack management plan can reduce readmissions by 20%. This is a Phase 3, open-label, multicenter randomized controlled trial involving 1400 patients across 30 NHS trusts.