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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This research aims to find out if giving plasma from a donor who recently had Chikungunya infection to newborns whose mothers have peripartum Chikungunya infection can improve the chances of newborns surviving without brain inflammation or damage within the first five days of life. The study will compare these results with a group of newborns who did not receive plasma transfusion due to delays in diagnosis or transfer, or parental refusal. The trial is led by the Centre Hospitalier Universitaire de la Runion and includes newborns up to 2 days old. Participants in the treatment group will receive a plasma transfusion from donors who declared Chikungunya infection less than six months ago. This treatment is given to newborns whose mothers were diagnosed with Chikungunya infection around the time of birth. Newborns will be treated within 12 hours of birth or diagnosis depending on timing. There is also a parallel observational group of newborns who will not receive plasma but will be monitored as part of standard care. During the study, newborns will have daily medical and biological tests from day 1 to day 7, and a follow-up visit between 1 and 3 months of age. For the observational group, data collected during routine care up to 3 months will be used for research. Researchers will measure the effectiveness of early plasma administration in preventing neonatal brain inflammation or damage within five days after treatment. Safety and health will be monitored throughout the trial period, which is planned to end in late 2027.
Actively Recruiting
Healthy Volunteer
Researchers are studying automated fetal heart function parameters to see if they differ between healthy babies and those with congenital heart disease. This international multicenter observational study aims to find out if these automated measurements can better predict heart complications like hydrops compared to current cardiovascular scores. The study focuses on pregnancies with and without fetal heart defects to compare cardiac function over time. Participants will have two fetal cardiac function ultrasound scans one between 27 weeks and 29 weeks plus 6 days of pregnancy, and another between 34 weeks and 36 weeks plus 6 days. These scans use both clinical and advanced research ultrasound systems to capture detailed heart measurements, including heart size, valve function, blood flow, and contractility. The study collects images and data securely and follows participants until delivery and hospital discharge. During the study, women will undergo standard pregnancy ultrasounds alongside research scans assessing various heart function parameters. Researchers will analyze these detailed images and functional data to compare healthy and affected fetuses. They will also evaluate if adding automated measures improves prediction of complications like hydrops. Data confidentiality is maintained, and results will be published while protecting patient privacy. The entire pregnancy period is observed, with data collected at two specific gestational windows.