Aulnay Sous Bois

Food Protein Induced Enterocolitis Syndrome FPIES is a type of non-IgE mediated food allergy that usually occurs in infancy and is often not well known by clinicians. The study aims to collect clinical information and allergy test results from children diagnosed with the acute form of FPIES and to observe their condition over three years. It seeks to better understand the evolution of FPIES, including atypical forms, with no prior prospective data available from France. Children diagnosed with acute FPIES will be followed in this national prospective study conducted at sixteen French centers. Allergy tests such as oral food challenges, skin prick tests, and IgE blood tests will be used for diagnosis and monitoring. Patients will be seen at an initial visit and then annually for up to three years. If tolerance to the offending food is not acquired, an oral food challenge will be performed in the hospital for confirmation. Participants will undergo yearly allergist visits for evaluation of symptoms and allergy testing. Researchers will measure the rate of tolerance acquisition to foods over one, two, and three years post-inclusion, as well as the progression to IgE sensitization and clinical IgE-mediated allergy. Additional outcomes include the presence of multiple FPIES episodes and related atopic conditions. The study will provide insights into the natural history and management of FPIES in children.

Autism spectrum disorder ASD is a developmental condition characterized by ongoing challenges with communication, social interaction, and repetitive behaviors that affect daily life in social and educational or professional settings. This trial explores a new approach using videodrama sessions to better understand the sensory experiences of children with ASD, aiming to improve therapeutic support and encourage interaction and play with others. The study focuses on children aged 3 to 15 years who show a strong interest in screens and videos. Participants in the experimental group will engage in 18 weekly videodrama sessions. Each session includes watching a video excerpt, playtime with toys and shapes, drawing activities, and group discussions. The materials used for play and drawing are consistent across sessions and groups. A comparison cohort will receive standard care without videodrama sessions. This design allows researchers to evaluate the impact of the videodrama therapeutic device on sensory and social behaviors. Throughout the study, researchers will collect data using questionnaires such as the Dunn Sensory Profile, Cars-T, and Sceno Test, all after 9 months. These assessments will help measure sensory processing and social communication. The study runs until 2027 and involves regular monitoring of participants progress and responses to the videodrama sessions, aiming to better tailor therapies for children with ASD.

Researchers are evaluating the use of arginine-vasopressin AVP and hydrocortisone compared with norepinephrine to improve survival and neurological recovery 30 days after cardiac arrest in patients experiencing hemodynamic failure. This phase 3, multicenter trial focuses on patients who have been successfully resuscitated but face post-resuscitation syndrome, which includes multiple organ failures and brain damage caused by a combination of heart and circulatory problems often linked to hormonal imbalances. The study randomly assigns participants to one of four groups AVP with placebo hydrocortisone, placebo AVP with hydrocortisone, both AVP and hydrocortisone, or placebo for both. AVP is given via infusion to maintain a target blood pressure for up to 3 days, while hydrocortisone is administered intravenously every 6 hours for 7 days without tapering at the end. Placebo treatments are used to compare effects. The trial involves 17 intensive care units in France and aims to enroll 380 patients. Participants will be closely monitored throughout the study with assessments including neurological outcome measured at day 30, along with various mortality causes and brain damage evaluations at 48 and 72 hours. Researchers will track survival, brain function recovery, and hemodynamic stability during and after treatment. The study uses quadruple masking to ensure unbiased results and includes ongoing safety and follow-up evaluations until December 2025.