Sodra Sunderbyn

Researchers are conducting a phase III randomized, open-label, multicenter trial across several countries including Sweden, Norway, Finland, Denmark, Italy, Australia, and New Zealand. The study focuses on elderly patients with untreated diffuse large B-cell lymphoma (DLBCL), defined as patients aged 80 years or older, or those aged 75 years or older who are considered frail based on a simplified Comprehensive Geriatric Assessment. The trial aims to compare the effectiveness of two treatment regimens in this population. Participants are randomly assigned to receive either the standard R-miniCHOP treatment or an experimental R-pola-miniCHP regimen where vincristine is replaced with an immunoconjugate, polatuzumab vedotin. Both treatments involve cycles of drugs including rituximab, cyclophosphamide, doxorubicin, and prednisone, administered over 18 weeks. The trial includes a screening period lasting up to 4 weeks, followed by the active treatment phase, and then a follow-up period lasting up to 36 months after treatment completion. Throughout the study, participants will be monitored to measure progression-free survival over 2 years as the primary outcome. The study involves regular assessments including clinical evaluations and safety monitoring. Enrollment began in the first quarter of 2020, with the last patient visit expected by the first quarter of 2027, allowing for long-term observation of treatment effects and patient outcomes.

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 evaluating a new e-health program called INSPIRE designed to support the brain development of very preterm infants born before 32 weeks or with low birth weight. The program focuses on helping parents develop responsive caregiving behaviors to improve multiple areas of the child's development such as cognitive, motor, feeding, language, and social-emotional skills. The study aims to see if this intervention improves child development up to 2 years of age, as well as examining parental stress, parent-child emotional connection, health inequalities, and gender effects. The INSPIRE intervention involves digital e-health sessions delivered to parents after hospital discharge, with a total of 18 sessions over two years. It uses video interaction to guide parents in strengthening their interactions with their infants and empowering them to respond to their child's needs in positive ways. Families will be randomly assigned to receive either the INSPIRE program or standard care, with the goal of assessing the program's impact compared to usual support. Participants and their families will be followed and assessed regularly up to the child's corrected age of 24 months. Researchers will measure the child's development using the Bayley Scales of Infant Development and evaluate parental experiences and stress. The study includes ongoing monitoring of child and parent outcomes to understand the intervention's effects and aims to establish a sustainable nationwide program to support preterm infants and their families, especially benefiting those far from specialized healthcare.