Ystad

Researchers are evaluating new disease descriptions and management guidelines for breath-holding spells in children under 5 years old in southern Sweden. The study aims to determine if these guidelines reduce unnecessary diagnostic procedures and are safe to use. It also investigates whether iron supplements decrease the frequency and severity of these spells and explores what information and support parents need for managing their childrens condition. Children diagnosed with typical breath-holding spells will be managed according to the new guidelines, which include cardiac evaluations like ECG for those with relevant family history or symptoms, and blood tests for anemia and iron deficiency if the child has multiple spells. Children with non-typical spells will be assessed individually using current practices. If iron deficiency is identified, supplementation is recommended. Some parents of children with frequent spells may participate in interviews as part of a sub-study. Participants will be evaluated by medical doctors and monitored through digital surveys over time. Researchers will assess the safety and usability of the guidelines, the effectiveness of iron treatment, and the support needs of parents. The study includes follow-up for up to 36 months to monitor outcomes and uses interviews and surveys to gather detailed information from families. The total participation duration varies, with specific assessments scheduled within weeks to months after inclusion.

Researchers are evaluating the impact of two different guidelines for monitoring labor progress on neonatal and maternal outcomes. The study compares the World Health Organizations Labour Care Guide LCG with standard delivery care in Sweden. The goal is to see if using the LCG can reduce adverse neonatal outcomes and lower the rate of intrapartum Cesarean sections. This study uses a multicenter, stepped-wedge cluster randomized design to explore these effects along with economic considerations and experiences related to childbirth. Participants will receive labor monitoring either according to the WHOs LCG guidelines or standard care. The study will involve multiple delivery units in Sweden, and women in active labor will be randomly assigned to either group as the new guidelines are gradually introduced. Alongside the main study periods, researchers will examine perinatal interventions, labor complications, and collect qualitative data through questionnaires, focus groups, and interviews with women, their partners, and healthcare providers. During participation, women and their partners will be asked about their childbirth experiences, while providers compliance and views on using the LCG will also be assessed. The study will track outcomes such as perinatal mortality, neonatal morbidity, cesarean section rates, and obstetric events like postpartum hemorrhage and labor duration. Data collection and follow-up will occur from 12 weeks up to 18 months after delivery, including economic evaluations and provider experiences to fully understand the effects of the labor monitoring methods.

Researchers are evaluating early treatment with peripheral intravenous noradrenaline compared to standard fluid therapy in adults with low blood pressure or shock in Danish and Swedish Emergency Departments. The study aims to see if early noradrenaline can help control shock faster, reduce ICU admissions, and lower mortality rates. This is a pragmatic, multi-center, randomized trial focused on improving emergency care for hypotensive patients. Participants will be randomly assigned to receive noradrenaline infused at 0.05-0.15 mcgkgmin for up to 24 hours in the Emergency Department until shock control is achieved. If shock control is not reached within 24 hours, or treatment cannot be stopped, patients will be transferred to the ICU for further care without continuing the trial intervention. The comparison group will receive standard care, which includes fluid therapy and ICU transfer if needed but no noradrenaline during the ED stay. During the study, patient data will be collected from bedside monitoring, electronic health records, and national registries. One year after enrollment, participants will be contacted to assess their physical function and daily self-care ability. The primary outcome measures the proportion of patients achieving target blood pressure 90 minutes after inclusion. Secondary outcomes include ICU-free days alive within 30 days, time without shock within 24 hours, and mortality rates at 30 days and hospital discharge.

Researchers are investigating the management of febrile infants aged 60 days or younger who visit pediatric emergency departments PEDs in Sweden. The study evaluates a new clinical guideline compared to current standard practices across 11 PEDs. This observational study aims to improve care by reducing unnecessary diagnostic tests, hospitalizations, and broad-spectrum antibiotic use, which have implications for patient comfort, healthcare resources, and environmental impact. The study will implement the new guideline in 7 PEDs while 4 PEDs will continue their usual care as a control group. All febrile infants aged 60 days or younger with a body temperature of 38.0C or higher, measured at home or in the PED, will be included. The research collects clinical data including fever details, gestational age, birth weight, symptoms, lab results, and diagnoses to refine and personalize management recommendations. Participants will be observed during their visit to the PED, with data gathered on investigations, treatments, and hospitalizations. The primary measure is how effectively the new guideline identifies cases of meningitis, bacteremia, and urinary tract infections, including any delays in treatment, tracked over 10 days. Secondary measures include prevalence of infections, clinical signs, and adherence to the guideline. The study plans to enroll at least 2,500 infants over approximately two years, with careful monitoring of outcomes and resource use.

Spontaneous intracerebral hemorrhage ICH is a serious type of stroke with high death and disability rates. Researchers are investigating whether a structured treatment package called a Care Bundle can improve the 3-month outcomes for patients with acute ICH compared to standard care. The study is an international, multicenter, parallel, cluster-randomized clinical trial focusing on implementing this Care Bundle in high-income countries, building on results from previous trials mostly done in low- and middle-income countries. The Care Bundle includes early intensive blood pressure lowering, treatment of fever and high blood sugar, rapid reversal of oral anticoagulation, and timely referrals to intensive care or neurosurgery when needed. Hospitals are randomized in batches through three phases usual care, randomized evaluation of the Care Bundle versus usual care, and a post-implementation follow-up where all hospitals apply the Care Bundle. Each batch lasts 18 months, with 6 months per phase, and the overall study rollout spans 2.5 years. Participants are adults aged 18 or older diagnosed with spontaneous ICH confirmed by imaging within 24 hours of symptom onset. During the study, patient management details and outcomes will be closely monitored, including brain imaging, blood pressure, glucose levels, and functional status. The primary outcome is functional recovery measured by a utility-weighted modified Rankin Scale score at 180 days. Secondary outcomes include disability, death, and health-related quality of life. The study also collects data on treatments and care decisions to evaluate the Care Bundles effectiveness and sustainability.

Researchers are evaluating whether adding a digital-physical treatment tool called Evira to obesity medications can improve treatment outcomes in adolescents with obesity. The study focuses on patients aged 12 to 17 years and aims to compare the combined approach of medication plus Evira with medication alone. Obesity medications liraglutide and semaglutide have shown some effects in this age group, but long-term success is limited, prompting the need for optimized treatment strategies. This randomized controlled trial assigns participants to one of two groups one receiving liraglutide or semaglutide with the Evira digital tool, and the other receiving medication alone with standard clinic support. The Evira tool includes a digitless scale used daily at home, linked to a mobile app that tracks weight trends using BMI standard deviation scores and allows communication between families and healthcare professionals. The study follows participants for six months to assess outcomes. Participants will undergo physical exams, provide background information, and complete electronic questionnaires. Researchers will monitor changes in BMI SDS from treatment start to six months, along with treatment adherence, side effects, and perceptions of the digital tool by both patients and professionals. Quality of life assessments will also be collected. The study is conducted across multiple centers in Sweden and sponsored by Karolinska Institutet.

Researchers are evaluating a Scandinavian decision support tool designed to help manage children with mild and moderate head injuries who seek care in emergency departments. The study focuses on whether these guidelines can reliably identify children with important complications, such as bleeding in or around the brain, following head trauma. This is a prospective, multicenter observational study including hospitals in Sweden and Norway that routinely treat children with traumatic brain injuries. The study involves no changes to usual care all children receive standard management regardless of participation. Data is collected on patient history, symptoms, and treatment during the emergency visit and entered into electronic case report forms. Follow-up is conducted through medical records and electronic questionnaires sent to guardians at 1, 3, and 4 months after injury, with long-term outcomes assessed beyond 6 months. A sub-study will also explore blood and saliva biomarkers to predict brain injury in certain cases. Participants will be monitored through clinical examinations, CT scan results, and questionnaires about recovery. The study measures outcomes like clinically important brain injury within one week, need for neurosurgery, CT findings, hospital admission, and time to full recovery. Safety and long-term effects are followed for up to four years. Data is analyzed to assess how well the Scandinavian and other international guidelines predict outcomes for children with head trauma.