Postextubation swallowing disorders (SD) are common in the intensive care unit (ICU) and are associated with severe complications, including aspiration pneumonia, a three-fold increase in reintubation risk and higher mortality. While fibreoptic endoscopic evaluation of swallowing (FEES) and videofluoroscopy are gold standards for diagnosis, they are often impractical or impossible to perform on intubated patients. The use of ultrasound offers a non-invasive, bedside alternative to evaluate the musculoskeletal structures involved in swallowing. The Echographie Identifier les troubles de Déglutition Acquis en Réanimation (EIDAR) study aims to evaluate the diagnostic performance of pre-extubation ultrasound in identifying patients at risk of SD following mechanical ventilation.

This prospective, monocentric diagnostic study conducted at the Dijon University Hospital ICU will include 100 adult patients ventilated for ≥48 hours. The primary outcome is the presence of SD, defined as a Penetration-Aspiration Scale score >2 during a FEES procedure performed 3 to 24 hours postextubation and independently assessed by an otolaryngologist blinded to index test results. Pre-extubation cervical ultrasound (Index Test) will be performed within 3 hours prior to extubation and measure hyoid bone ascension (primary variable of interest), geniohyoid muscle surface area and digastric muscle cross-sectional area. The diagnostic performance of cervical ultrasonographic parameters will be assessed using their discriminative capacity via a receiver operating characteristic curve. The feasibility of the ultrasound procedure in a critical care setting will also be assessed.

The study received a favourable opinion from the independent ethics committee CPP Ouest III and is registered with the French health authority ANSM (national agency on safety in medicine and health products). It is conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Participants or their proxies provide free and informed oral consent. Results will be submitted for publication in peer-reviewed medical journals and presented at international conferences.

RCB 2023-A00461-44 and NCT05922085

Neonatal encephalopathy, particularly situations involving neonatal hypoxic–ischaemic encephalopathy (NHIE) and neonatal stroke (NS), covers complex neonatal conditions associated with a risk of neurodevelopmental difficulties. Early prevention programmes have shown benefits for neurodevelopment, but few address both NHIE and NS populations. Following an initial joint development phase with families and professionals, we identified two areas of intervention: (1) Making infant care and referral more streamlined and (2) Increasing parent empowerment. The PRevention and support for Parenthood in an early Rehabilitation programme is a multidisciplinary intervention initiated in the neonatal intensive care unit and continuing at home until the infant reaches a corrected age of 4 months. Its objectives are to: (1) Ensure that the family environment is adapted to the child’s needs, (2) Introduce parents to digital support suggesting information on the care pathway and developmental interventions, (3) Maintain continuity of care and (4) Maximise early detection by sharing videos for analysis of the child’s movements.

This longitudinal study uses a mixed-methods approach to assess the acceptability and feasibility of the early parenthood support programme involving parents and healthcare professionals. The qualitative research will be carried out through focus groups (parents and professionals) held at the end of the intervention programme. The corpus of semidirected collective interviews (focus group) will be processed by thematic content analysis. Initial coding and analysis will be conducted by the sociologist with expertise in qualitative methods, and the emerging themes and interpretations will then be discussed, refined and validated through interdisciplinary analysis meetings involving the broader research team. This collective analytical process will allow for deeper engagement with the data and ensure that interpretations are challenged and enriched by multiple professional perspectives. The quantitative research will rely on self-administered questionnaires (parents and professionals), assessment of child neurodevelopment using standardised tools by physiotherapists and assessment of parental skills using standardised observation grids.

This study has full approval from an independent ethics committee (CPP Ile de France I). Its findings will be published in peer-reviewed journals and conference presentations. The trial was registered on Clinicaltrials.gov (NCT05457569).

Giant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme.

This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12–36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years.

The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety—ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations.

NCT06037460.