Clinical trials

Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term. The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established. The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture. This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group. Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.

The main reason for insufficient control of celiac disease is non-adherence to the gluten-free diet (GFD), whether voluntary or involuntary. In children, involuntary exposures are common (canteens, snacks, restaurants). There are no evidence-based recommendations regarding the best way to follow up with patients and assess adherence to the diet. Monitoring of celiac disease is traditionally based on IgA anti-transglutaminase (IgA anti-tTG) serology, but it reflects a delayed immune response and does not detect occasional exposures. Numerous studies conducted outside of France seem to highlight the usefulness of measuring gluten immunogenic peptides (GIP), compared to the current tools used. Measuring GIP in urine, which is non-invasive and can be performed regularly, could allow for earlier and more objective detection of recent gluten exposure, particularly inadvertent exposure, even before symptoms appear. Furthermore, it could serve as a complementary test for patients who continue to show symptoms or positive serology despite a reported well-followed GFD. In such situations, the use of control esophagogastroduodenoscopy (EGD) with jejunal biopsies could be reconsidered in the event of positive urinary GIP. This is the first study conducted in France on the usefulness of urinary measurement of immunogenic gluten peptides in the follow-up of pediatric celiac patients.

This study aims to identify perceived barriers and facilitators to regular physical activity among children and adolescents with inflammatory bowel disease (IBD) followed in pediatric gastroenterology. Approximately 60 participants aged 10-17 years will complete two self-administered questionnaires (CAPAS-Q for physical activity/sedentary behavior and IMPACT-III for health-related quality of life) and take part in a single semi-structured interview exploring experiences, obstacles, and levers to support sustainable physical activity. Relevant clinical data (disease characteristics, treatment and selected routine clinical parameters) will be extracted from the medical record. Participation is limited to one visit (about 45-60 minutes) during a routine hospital appointment, with no additional intervention or follow-up required.

Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. One important reason is that intravenous pain medication can be technically difficult, stressful, or delayed in paediatric patients. Intranasal drug administration, which involves spraying medication into the nose, offers a rapid and needle-free way to relieve pain and is increasingly used in paediatric emergency care. Two medications can be administered through this route: ketamine and sufentanil. Intranasal ketamine is already widely used in children for pain management. Sufentanil is a potent opioid analgesic commonly used in adults and in anaesthesia but has been much less studied in children when administered intranasally. The aim of this study is to compare the effectiveness and safety of intranasal sufentanil and intranasal ketamine in children aged 6 to 17 years who present to the emergency department with severe traumatic limb pain. Both medications will be given in addition to standard care, including the routine use of an oxygen-nitrous oxide gas mixture (MEOPA), which is commonly used to reduce pain and anxiety in children. Children who take part in the study will be randomly assigned to receive either intranasal sufentanil or intranasal ketamine. Pain levels will be assessed at regular time points after medication administration using age-appropriate pain scales. Sedation level and possible side effects will also be closely monitored for a short period following treatment. The hypothesis of this study is that intranasal sufentanil will provide greater pain relief than intranasal ketamine 30 minutes after administration, without increasing the risk of adverse effects, when both are used alongside standard emergency care. The results of this study are expected to improve knowledge about fast, effective, and non-invasive pain relief strategies for children in emergency settings and may help optimise future pain management protocols in paediatric emergency care.

Introduced in 1930, photoplethysmography techniques presented the possibility of measuring SpO2 and heart rates (HR) using the absorption of light by the blood to define these signals. In recent years, a new approach to photoplethysmography to measure physiological parameters without contact has been developed. This technique, called remote Photoplethysmography Imaging (rPPG), uses the different Red - Green - Blue color spectra at a skin captured by the camera video to determine a plethysmography signal. However, it has never been studied in pediatric patients. The objective is to evaluate the remote photoplethysmography technology to measure vital signs in pediatrics

Transitional psychiatry addresses the complex process through which individuals move from adolescence to adulthood, both in terms of developmental stage and mental healthcare systems. This transition includes the shift from pediatric to adult psychiatric services, as well as the evolution from vague or subclinical symptoms to established psychiatric disorders that may become chronic without early intervention. Psychiatric disorders often emerge early in life: approximately 50% before age 15 and 75% before age 25. Early detection and intervention are therefore crucial to improving long-term mental health outcomes, functional independence, and social integration. However, current healthcare systems frequently fail to meet the needs of adolescents and young adults during this critical transition phase. Organizational discontinuities and clinical complexity lead to several risks: * Difficulties in accessing appropriate psychiatric care for adolescents presenting with emerging symptoms, * High rates of service disengagement for patients already receiving pediatric mental health care who do not successfully transition to adult services. Studies have shown that nearly half (48%) of young people drop out of psychiatric follow-up for at least three months after reaching adulthood. This interruption increases the likelihood of relapse and involuntary psychiatric admissions. Despite numerous publications over the past decade emphasizing the need for dedicated transitional care models, services remain fragmented in many systems. One of the largest recent studies in this area, the European MILESTONE longitudinal study, followed 763 patients (mean age 17.5) over two years in eight countries. It found that 11% of participants discontinued care entirely, 41% experienced discontinuity, and only 21% successfully transitioned to adult psychiatry. Continued care was more likely among patients with severe psychiatric disorders who had already accepted treatment. In contrast, those with mood disorders or poorly defined symptoms-despite being at high risk-were less likely to receive ongoing support. Transitional psychiatry therefore aims to establish integrated practices and systems that ensure the continuity of mental healthcare for youth aged approximately 16 to 25. The main objectives of such services are to: * Prevent care disruptions at the age of majority, * Maintain appropriate and developmentally sensitive treatment for young adults, * Promote patient autonomy in managing their care, * Ensure coordination and collaboration between child/adolescent and adult psychiatric teams. Despite growing recognition of these needs, no consensus exists in the literature regarding a fixed duration that defines a true care discontinuity, and practices vary significantly between regions and systems. In this context, the Odyssée 3 project was launched in Nice, France, as a prospective epidemiological study focusing specifically on the real-life transition from child and adolescent psychiatry to adult psychiatry. The study targets a cohort of 17-year-olds who are currently receiving mental health care and will soon face the shift to adult services. The project is part of the CNR Santé Mentale territorial initiative, supported by the Regional Health Agency (ARS 06). It is co-led by the University Department of Child and Adolescent Psychiatry (SUPEA) at Lenval Pediatric University Hospital and the Department of Psychiatry at the Nice University Hospital (CHU de Nice). Odyssey 3 has three primary goals: * To assess the care pathways and clinical outcomes of adolescents undergoing transition to adult psychiatry; * To identify patient profiles, trajectories, and risk factors associated with successful or failed care continuity; * To generate data that will inform the creation of a dedicated transitional psychiatry team and pathway in the Nice area. Ultimately, this study aims to strengthen the healthcare system's ability to detect early warning signs, intervene proactively in emerging psychiatric conditions, and ensure that adolescents already engaged in care do not experience service discontinuities. Its findings will serve as a foundation for building a specialized, coordinated, and sustainable transitional psychiatry structure in Nice, aligned with best practices and international recommendations.

The incidence of type 1 diabetes is increasing, with an incidence of +4% per year in France today. The treatment for type 1 diabetes is insulin therapy. In recent years, new systems have emerged, so-called "semi-closed loop" systems, also called automated insulin therapy, which have proven their superiority in terms of quality of life and glycemic balance in adults and children over 6 years old. Since January 24, 2024, the HAS now recognizes the indication of the semi-closed loop for the YPSOPUMP model in children aged 2 to 6 years. This is the first reimbursement in France of a closed loop system for the 2-6 year old age group. There are currently few studies comparing the quality of life of children in semi-closed loop versus other treatments (open loop or injections). Regarding quality of life, the studies found mainly concern the contribution for parents and the improvement of adolescents' sleep as in the study by Erin C Cobry et al from 2020 (6). Our study therefore aims to demonstrate an improvement in quality of life but also in diabetes balance in type 1 diabetic patients on a closed loop insulin pump versus open loop or injections in the pediatric population aged 2-6 years.

This project aims to answer to the question of EMDR effectiveness in young children and to determine whether or not the therapy effectiveness is related to the level of cognitive functioning in young children. The study requires a total of 60 children, girls and boys, aged 3 to 6 years and presenting disorders related to stressors, anxiety and/or trauma. Participants will be randomly distributed in two groups: "EMDR therapy" (N=30) group or "control therapy" (N=30) group. The study will take place in four stages: 1/ Pre-treatment phase : An evaluation of child's various cognitive and executive functions, child's symptomatology and parental distress is planned in a pre-treatment phase. 2/ Treatment phase : An EMDR therapy or a routine care is administered to the child between 6 to 10 weeks. 3/ Post-treatment phase : A reassessment of child's and parent's symptoms is planned at the end of treatment. 4/ Continuation of treatment: Children who have received control therapy and without symptomatic improvement will be proposed EMDR treatment. These children will receive the same symptomatic assessments at the end of EMDR treatment. A significant reduction in disorders related to trauma or stress and anxiety factors and their symptomatology, as well as comorbid disorders and their symptomatology, is expected in children who received EMDR therapy compared to the group who received a control therapy. These results are expected to be robust over a period of at least 3 months. The positive effects of EMDR on child symptomatology are also expected to be more pronounced in children showing higher levels of cognitive functioning

This project aims to elucidate the complexities of the preventive approach among young people involved in intensive sports activities, providing valuable recommendations to optimize their physical, mental, and social health both in the present and in the long term. The multidisciplinary skills of a team of researchers in sports science and health will contribute their recognized disciplinary expertise through international publications, as well as solid experience in the demands of elite sports, along with a commitment to transferring innovative knowledge toward a preventive approach to sports training. The main objective is to determine whether a somatotype aligned with the discipline's expectations protects the athlete in terms of self-perception and, consequently, reduces health-risk behaviors. Secondary objectives will include linking somatotype, growth, psychological changes (self-perception), and the emergence of health-risk behaviors or injuries in these young athletes.

The investigator would like to create a prospective cohort of patients in order to describe eosinophilic esophagitis with the specificities corresponding to our geographical territory, and to study their evolution at 3 months, 6 months, 12 months, 18 months and 24 months. This study would also enable us to investigate the quality of life of these chronically ill patients

Clubfoot is an orthopedic congenital malformation of the lower limb of the newborn evaluated by the Dimeglio score. There is a deficit of muscular balance between the agonists and antagonists to the deformity. The Dimeglio score takes into account the muscular activity but only up to one point out of 20. This study proposes to use a muscle scale inspired by the Dimeglio score to see if there is a correlation between muscle activity and the risk of tenotomy before 1 year. It will also assess the inter-examiner reproducibility of this scale. This study is a prospective cohort study with a duration of 8 years to include about 100 feet. Infants with idiopathic Clubfoot treated with the functional method at up to 15 days of life will be included. Feet will be assessed at an inclusion visit and then at 3-6-12 months. The primary endpoint will be the need for Achilles tenotomy before 1 year of age. The secondary endpoint will be inter-examiner reproducibility determined by statistical analysis. The expectation of this study would be to define a predictive factor of the evolution of the PBVE in order to refine the treatment earlier.

Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. This disease is usually unknown by clinicians. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. The aim of the study is to collect clinical features and allergy testing of children who have acute form of FPIES at diagnosis and during evolution during three years