Azumino

Researchers are evaluating whether an investigational drug called OHB-607 can prevent Bronchopulmonary Dysplasia (BPD), a common chronic lung disease, in extremely premature infants. The study compares infants receiving OHB-607 alongside standard neonatal care to those receiving standard care alone to reduce the burden of this lung condition. This is a Phase 2b, multicenter, randomized, open-label study focused on safety and clinical efficacy. Participants will receive an intravenous infusion of OHB-607 from birth until reaching a postmenstrual age (PMA) of 29 weeks and 6 days. The study includes two arms: one group receives the investigational drug plus standard care, while the other group receives only standard neonatal care. The treatment period ends at 29 weeks plus 6 days PMA, after which infants are monitored. Throughout the study, researchers will track the incidence of severe BPD or death up to 36 weeks PMA, whichever occurs first. Assessments will include clinical evaluations and monitoring for safety and any side effects. The study also involves long-term follow-up to observe the infants' health outcomes beyond the treatment period. Participation involves consent from parents and collection of birth and medical history information.

Researchers are evaluating the effects of the Close Collaboration with Parents intervention, a family-centered care approach for neonatal intensive care unit (NICU) staff, on parents of newborns in the NICU. This study aims to assess how parents rate the quality of family-centered care, measure parental anxiety symptoms, and evaluate readiness for discharge. The study compares data collected from parents before and after implementing this intervention. The intervention involves educating NICU healthcare staff to better observe infant behaviors, support parents in participating actively in their infant's care, understand family experiences, and involve parents in decision-making from early care through discharge preparation. The study includes a pre-intervention data collection phase from September to December 2023, the intervention phase from January to December 2024, and a post-intervention data collection phase from January to April 2025. During the study, data will be gathered from parents whose infants have been admitted to the NICU for at least two weeks. Researchers will collect information, including parent ratings of family-centered care quality, parental anxiety, and discharge readiness. Data will be securely managed and analyzed using statistical methods to adjust for factors like length of stay and parental mental health history. The study plans to monitor the quality of family-centered care as the primary outcome at the time of infant discharge, around one month of age.

Researchers are collecting detailed information about very premature infants born at 22 to 23 weeks of gestation and their mothers to better understand outcomes and treatments in neonatal intensive care units. This registry aims to gather data from multiple hospitals to track and evaluate the health, care, and progress of these extremely premature infants. The study gathers baseline observational data on mothers and infants, including demographics, maternal health, labor and delivery details, infant health, medical treatments, and clinical outcomes. Participating hospitals use this information to improve quality of care, analyze relationships between patient characteristics and treatments, and observe trends in disease and therapy. Participants include all local births within the specified gestational age range and outborn infants admitted to NICUs at these gestational ages. Data collection continues longitudinally through January 2028, providing ongoing reporting and tracking of outcomes for these infants and their mothers.

Researchers are evaluating the long-term safety, tolerability, and effectiveness of marstacimab as a preventative treatment for people with severe hemophilia A or moderately severe to severe hemophilia B, including those with or without inhibitors. This open-label extension study includes participants from two earlier Phase 3 studies: one with adolescents and adults aged 12 to under 75 years, and another ongoing study with pediatric participants under 18 years old. The goal is to continue monitoring these participants who did not require early termination in the prior studies. Participants will receive marstacimab administered by subcutaneous injection using a prefilled pen or syringe. Dosage varies by age group: those 12 years and older start with a 300 mg loading dose followed by 150 mg weekly, with the option to increase to 300 mg weekly if needed. Children aged 6 to under 12 years receive a 150 mg loading dose followed by 75 mg weekly, with possible escalation to 150 mg weekly. The study allows use of prefilled syringes where pens are not available, and includes an optional substudy for some participants from the earlier adult study. Throughout the study, participants will attend scheduled visits for assessments including physical exams, laboratory tests, and safety monitoring lasting up to 7 years. Researchers will track adverse events, serious side effects, thrombotic events, injection site reactions, immune responses to the drug, and changes in vital signs or lab values. This extended observation helps to understand marstacimab’s long-term effects and supports safer dosing decisions across different age groups.