Sudden Infant Death Syndrome (SIDS)

Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.

Researchers are investigating treatments for children aged 1 to 18 years with chronic kidney disease (CKD) and proteinuria, conditions where the kidneys do not function properly and leak protein into the urine. CKD can cause complications like high blood pressure, and treatments currently include ACE inhibitors (ACEI) or angiotensin receptor blockers (ARB) that help control blood pressure and protein levels. This study focuses on evaluating the safety and effects of adding finerenone to these standard treatments, aiming to better manage the overactive kidney system involved in these conditions. Participants will receive finerenone orally, adjusted by age and body weight, alongside their existing ACEI or ARB treatment. The study lasts about 19 months, with up to 18 months of finerenone treatment and a one-month follow-up. During this time, children who are new to finerenone will have at least 12 visits, while those already on finerenone will have at least 8 visits. At these visits, various health checks and sample collections will occur to monitor safety and kidney function. Throughout the study, researchers will regularly measure blood pressure, heart rate, temperature, height, and weight, and collect blood and urine samples to assess kidney function and protein levels. They will also perform heart tests using electrocardiograms and echocardiography. Participants and their guardians will answer questions about medication use and any medical problems experienced. Safety will be closely monitored by tracking any adverse events during the study and a health check will be done about 30 days after treatment ends.

This research aims to evaluate the potential benefits of acupuncture as a treatment for children aged 6 to 12 years with Attention Deficit Hyperactivity Disorder (ADHD). It compares acupuncture combined with traditional Chinese herbal treatment to herbal treatment alone, using a mixed-methods approach that includes data mining, treatment outcome assessments, and patient perspectives. The study seeks to provide a detailed understanding of acupuncture's role in managing ADHD symptoms, executive function, quality of life, and sleep quality. Participants will be assigned to either an experimental group receiving acupuncture alongside herbal medicine or a control group receiving only the herbal treatment based on Chinese Medicine clinical guidelines. Acupuncture treatments involve specific needles and techniques informed by prior data analysis of effective acupoints for ADHD. Herbal treatments follow established clinical guidelines for pediatric ADHD. The study includes three phases: acupoint data mining, clinical intervention with repeated assessments, and qualitative interviews with children, caregivers, and clinicians. During the 12-month study, children will undergo quantitative assessments such as the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL 4.0, PSQI, and CGI at baseline, post-treatment, and follow-up points to measure ADHD symptoms and related impacts. Qualitative interviews will explore treatment experiences and satisfaction. Researchers will analyze changes in symptoms, executive function, quality of life, and sleep, combining statistical methods with thematic analysis. The study starts in October 2024 and is expected to complete by May 2026.

This research aims to evaluate a new advanced wireless skin sensor system designed to monitor vital signs in healthy newborn infants of at least 35 weeks gestational age. The study focuses on assessing the feasibility, safety, and accuracy of this wireless system compared to the standard wired monitoring during the first two hours after birth, especially during unsupervised parental care in the obstetrical center. The goal is to improve early detection and prevention of Sudden Unexpected Postnatal Collapse (SUPC), a rare but serious condition affecting newborns shortly after delivery. Participants will have both the wireless monitoring system and the standard wired system placed on their chest and limb. For vaginal births, the wireless system is placed first, followed by the wired system after 15-20 minutes; for C-section births, the order of placement is randomized. Both monitoring systems remain in place for two hours to continuously record vital signs such as heart rate, respiratory rate, oxygen saturation, and skin temperature. During the study, newborns' vital signs will be recorded and compared between the two systems for up to two hours immediately after delivery. Researchers will evaluate the feasibility by checking for gaps in data and user satisfaction, assess safety through skin and pain scores, and measure accuracy using statistical comparisons. The study also includes monitoring the time between sensor placement and data display. Participation lasts only the initial two-hour period after birth, with monitoring done under real-world conditions in the obstetrical center.

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 Réunion 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.

Researchers are evaluating a new algorithm-assisted subjective refraction software designed specifically for children aged 6 to 12 years. This study aims to compare the accuracy of two versions of this software, each used with Vision-S™ and Vision-R™ phoropters, against the conventional subjective refraction method performed manually with the Vision-R™ phoropter. The research focuses on improving the standardization and accuracy of refraction assessments in children. The study has two phases: Phase A will validate the first version of the Kids refraction software (vA) and Phase B will evaluate the second version (vB), which includes additional steps to help manage the child's attention and cooperation. Participants will undergo subjective refraction tests using both software versions with Vision-R™ or Vision-S™ devices, as well as conventional subjective refraction with Vision-R™. Measurements will be taken under non-cycloplegic conditions, with some assessments also performed under cycloplegic conditions. Participants will have their visual acuity and refraction results assessed multiple times, including Sphere, Cylinder, and Axis measurements, starting from Day 1 and continuing up to 7.5 months. The study includes comparisons between non-cycloplegic and cycloplegic refraction results using various devices. Researchers will monitor visual acuity throughout the study to evaluate the software's performance. The total duration of participation for each child will be approximately 7.5 months.

Researchers are developing and managing the AnovaOS Network Powered Patient Registry to collect real-world patient data across various diseases globally. This registry aims to capture meaningful clinical information on diagnosis, infection course, treatments, and outcomes to enhance understanding and support future clinical trials and observational studies. The registry serves as a resource to better understand, prevent, diagnose, and treat diverse health conditions. Participants' data will be gathered through this registry, which can also be used to recruit individuals for clinical trials and observational studies on promising therapies. The registry collects ongoing information on patients' health status and treatments, enabling long-term monitoring and analysis. This observational study does not involve administering treatments but focuses on data collection and management. Participants will provide information through questionnaires or instruments, either personally or via an informed proxy, with an expected follow-up once per year. The research team will assess natural history, clinical effectiveness, safety, and quality of care over a period of five years. The registry includes patients with a wide range of conditions, and participation requires informed consent and the ability to complete follow-up data collection.

This research aims to evaluate the use of high-flow nasal cannula (HFNC) oxygen therapy to prevent low oxygen levels (hypoxemia) during anesthesia-induced tracheal intubation in children aged 2 to 10 years. Children have higher metabolic needs and are more likely to experience airway collapse and low oxygen during intubation compared to adults. Because spontaneous breathing stops at anesthesia induction, oxygen is rapidly used up, increasing the risk of serious complications. Ultrasound is also used to help diagnose stomach swelling during the procedure. Participants are randomly assigned to one of two groups. In the HFNC group, after the child stops breathing spontaneously, mask ventilation is done until oxygen levels reach 90%, then the mask is removed and HFNC oxygen is provided through nasal tubes to maintain oxygen during apnea. Intubation or laryngeal mask placement is performed afterward while HFNC continues. The control group receives no intervention. The study uses the AIRVO2 device for HFNC and monitors apnea time between 2 to 10 minutes. During the study, researchers will assess how long children can safely hold their breath without oxygen drops and monitor oxygen levels throughout the procedure. Children are evaluated for lung and heart health, cooperation, and anesthesia risk level before participation. The study includes triple masking to reduce bias and will run until November 2025. Safety and oxygenation effectiveness during intubation are the main focuses, with follow-up occurring during the perioperative period.

Researchers are evaluating the safety and effectiveness of using preoperative aerosol inhalation of Indocyanine Green (ICG) solution to improve thoracoscopic surgery for congenital lung malformations in children. This study focuses on children aged between 3 months and 14 years who have been diagnosed with congenital lung malformations, aiming to help surgeons accurately identify and remove affected lung tissue. Before surgery, children undergo pulmonary ventilation function evaluation and enhanced lung CT scans. Approximately 30 minutes before surgery, they inhale an ICG solution dissolved in saline at a dose of 0.5 mg/kg. During surgery, a fluorescence thoracoscope is used to clearly differentiate normal lung tissue from diseased tissue by fluorescence staining. The lesion boundaries are marked, and lung tissue is carefully dissected using specialized surgical tools. After removing the lesion, the surgical area is examined for bleeding or air leaks, followed by chest drainage tube placement. Participants are followed up 3 to 6 months after surgery with outpatient visits including pulmonary CT scans and lung function tests. Measurements such as tidal volume, inhalation/exhalation time ratio, peak time ratio, and peak volume ratio are compared before and after surgery. Researchers also monitor the rate of residual disease at 3 months and hospital stay length up to 14 days to assess outcomes and safety.

Myopia, especially among children and adolescents, is increasing worldwide and has reached epidemic levels in some Asian regions. Researchers are focusing on evaluating the use of atropine 0.01% eye drops as a treatment for progressive myopia in children. This observational study aims to build a database to share results and clinical experience, particularly within the French population where published data are limited. Participants in this study are children with active myopia who are treated daily with atropine 0.01% eye drops. The study involves collecting detailed ophthalmological and demographic data at regular intervals. These include measurements such as refractions, intra-ocular pressure, dilated eye exams, and biometry, all assessed every six months until participants reach 18 years of age. Throughout the study, participants will undergo comprehensive eye examinations and monitoring every six months to track changes and potential side effects like halos or photophobia. Researchers will gather data on treatment adherence and any undesirable events. The study spans from the initial treatment phase through to age 18, providing long-term observation of the treatment's impact and safety.