Ystad

Researchers are evaluating new disease descriptions and management guidelines for breath-holding spells in children under 5 years old living in southern Sweden. The study aims to see if these guidelines reduce unnecessary diagnostic tests, ensure safe clinical management, and assess if iron supplementation lessens the frequency and severity of spells. It also explores the types of information and support parents need for children with these spells. Children diagnosed with typical breath-holding spells will be managed following the new guidelines. Those with a family history or signs of heart disease will receive an ECG, and children with two or more spells will have blood tests to check for anemia and iron deficiency. If iron deficiency is found, iron supplements are recommended. Digital surveys will be given to parents, and children with frequent spells may be invited to participate in interviews. Participants will undergo evaluations by medical doctors, with follow-up lasting up to 36 months to monitor safety and guideline use. The study will measure the safety of the guidelines over this period and usability shortly after inclusion. Researchers will also assess the usability of the disease definition until the doctors complete their assessments. Parents will provide information through surveys, and some may join interviews to share their experiences and support needs.

Researchers are evaluating whether using the World Health Organization's Labour Care Guide (LCG) instead of standard care for monitoring labor progress can improve outcomes for newborns and mothers. This study compares these two guidelines to see if the LCG can reduce adverse neonatal outcomes, such as perinatal mortality, neonatal complications, and the need for cesarean sections during labor. The research also looks at other perinatal interventions, complications, and economic factors, using a multicenter, stepped-wedge cluster randomized trial design conducted from 2023 to 2025 in Sweden. Participants will receive care based on either the WHO's LCG or standard labor monitoring guidelines. The LCG is a next-generation partograph designed to follow the latest intrapartum care recommendations. The study involves multiple delivery units where women in active labor receive monitoring according to the assigned guideline. Researchers will compare outcomes such as neonatal morbidity, cesarean section rates, use of oxytocin, postpartum hemorrhage, labor duration, and experiences of women, their partners, and healthcare providers. Throughout the study, participants will be monitored for neonatal complications including low Apgar scores, hypoxic ischemic encephalopathy, intracranial hemorrhage, seizures, meconium aspiration syndrome, and neonatal unit admissions. The study will also assess maternal outcomes and collect feedback via questionnaires and interviews about childbirth experiences and guideline compliance. The primary outcomes are adverse neonatal events and intrapartum cesarean rates, with follow-up from 12 weeks up to 18 months after birth to gather comprehensive data on health and safety.

Researchers are conducting a pragmatic, multi-center, superiority, randomized clinical trial to compare early treatment using intravenously infused noradrenaline with fluid-only therapy in patients experiencing hypotension or shock in Danish and Swedish Emergency Departments. The study aims to determine if early noradrenaline can speed up shock control, reduce ICU admissions, and decrease mortality in non-bleeding hypotensive patients. Participants will be urgently treated during their Emergency Department stay with either noradrenaline or the usual fluid therapy. The treatment is administered through a vein and given early after presentation. After treatment completion in the Emergency Department, patient data will be collected from bedside measurements, electronic health records, and national registers. One year after inclusion, participants will be contacted to answer questions about their daily physical function and ability to care for themselves. Throughout the study, researchers will monitor blood pressure to assess the proportion of patients achieving target levels within 90 minutes of inclusion. Data will also include time to shock control, ICU admission rates, and mortality. The study includes ongoing safety monitoring and long-term follow-up to evaluate patient outcomes over the course of a year.

Researchers are evaluating a new clinical guideline for managing febrile infants aged 60 days or younger who visit pediatric emergency departments. Each year, about one million such infants present with fever in Europe and the United States. Although only a small percentage are diagnosed with serious infections like meningitis, bacteremia, or urinary tract infections, current guidelines recommend extensive testing, hospitalization, and broad antibiotic use. These practices may lead to medical overuse, stress for families, increased healthcare costs, and environmental impact. The study is a prospective observational trial conducted across 11 pediatric emergency departments in Sweden. Seven sites will implement the new guideline as standard care for infants with fever without a known source, while four sites will continue usual practices to serve as controls. The study expects to enroll at least 2,500 febrile infants over approximately two years. Data collected will include clinical signs, laboratory results, and management details to help improve and individualize care guidelines. Participants will undergo assessments including temperature measurement and clinical evaluations to identify serious bacterial infections. Researchers will monitor adherence to the new guideline, compare detection rates of infections between groups, and track any delays in treatment. Outcome measures include the proportion of infants correctly identified with meningitis, bacteremia, or urinary tract infections and those who experienced delayed antibiotic treatment. The study aims to optimize infant care while reducing unnecessary interventions and their consequences.

Spontaneous intracerebral hemorrhage (ICH) is a severe type of stroke accounting for 10-15% of all strokes but causing about half of stroke-related deaths and disabilities. Many patients with ICH have decreased consciousness when admitted, yet intensive care and neurosurgical treatments are not common. Prior studies in low- and middle-income countries showed that a treatment package including early intensive blood pressure lowering and managing fever and high blood sugar improved outcomes. The I-CATCHER study aims to test a similar structured Care Bundle approach in Sweden, Australia, and other high-income countries to improve treatment and prognosis for patients with spontaneous ICH. This study compares a Care Bundle involving early intensive blood pressure control, reversal of oral anticoagulation within 30 minutes, fever management, blood sugar control, and timely referrals to intensive care or neurosurgery against standard care. The Care Bundle targets specific blood pressure levels depending on initial readings and aims to avoid do-not-resuscitate orders or withdrawal of care for 48 hours. Repeat brain imaging is done as needed. Hospitals are randomized in batches over three phases lasting 18 months each: usual care, randomized evaluation, and post-implementation follow-up, with the entire study rolling out over 2.5 years. Participants are adults aged 18 or older with spontaneous ICH confirmed by imaging and admitted within 24 hours of symptom onset. Patient information, treatments, and outcomes are recorded, including functional status measured by the Utility Weighted modified Rankin Scale at 180 days. The study collects data on various treatments, monitoring, and complications to assess if the Care Bundle improves recovery. Safety and sustainability of the Care Bundle are evaluated through continued hospital participation and follow-up.

Researchers are investigating whether adding a digital-physical treatment tool called Evira to obesity medications can improve treatment outcomes in adolescents with obesity. The study focuses on adolescents aged 12 to 17 years who are being treated with obesity medications liraglutide or semaglutide. These medications have shown some effectiveness in reducing BMI SDS, but many patients regain weight after stopping the medication, highlighting the need for additional supportive treatments. Participants will be randomly assigned to one of two groups: one group will receive the standard obesity medication combined with the Evira digital treatment tool, which includes daily home measurements and continuous communication between healthcare providers and families via a mobile app. The other group will receive obesity medication with usual clinic support. The study will follow participants for six months, with two-thirds in the intervention group and one-third in the control group. During the study, participants will undergo physical examinations and provide background information. Questionnaires will be given electronically to both groups. The main measurement is the change in BMI SDS from the start of treatment to six months follow-up. The study aims to monitor adherence and treatment effects closely using the digital tool and clinic assessments over this six-month period.

Researchers are evaluating the Scandinavian guidelines designed to manage children with mild and moderate head injuries who visit emergency departments in Sweden and Norway. The study aims to determine how sensitive these guidelines are in identifying important patient outcomes, such as serious brain injuries, without introducing any new treatments. This observational study includes children under 18 years old who have suffered blunt head trauma within 24 hours and seeks to improve the accuracy of decision-making tools used in emergency care. Participants will be managed according to their hospital's usual care practices without any changes or experimental treatments. Doctors and nurses will collect detailed information about each child's injury, symptoms, and treatment in a web-based case report form. In some centers, a sub-study will collect blood and saliva samples within 12 hours of injury to analyze biomarkers that might predict brain injury. CT scans, when performed, will be reviewed by certified radiologists. During the study, follow-up information will be gathered from medical records and questionnaires sent to guardians at 1, 3, and 4 months after the injury, with additional long-term follow-up after 6 months. Researchers will track outcomes like the number of children with serious brain injuries within one week of trauma. Data will be analyzed statistically to assess how well the guidelines predict important outcomes and to explore the potential of biomarkers to reduce unnecessary CT scans. The study plans to enroll up to 5,300 children over about four years.