Clinical Research Directory

Optimal Defaults Grocery Shopping Intervention to Promote Healthy Diets for Pediatric Cancer Survivors and Their Families

This clinical trial tests the feasibility, acceptability and effect of an optimal defaults grocery shopping intervention to promote healthy diets for pediatric cancer survivors and their families. Pediatric cancer survivors are a growing population who are at an increased risk of developing chronic conditions and treatment-related complications. Poor nutritional intake can significantly worsen chronic health conditions experienced by survivors. Children who have poorer nutrition post-treatment are at greater risk for cancer recurrence. Interventions that effectively support families in obtaining and consuming healthier food and improve dietary intake are poised to improve developmental outcomes among pediatric cancer survivors. One promising way to impact the family diet is by targeting food purchasing. Optimal defaults, or making the healthy choice the automatic choice, is a specific nudge strategy that may be a feasible, acceptable and effective way to promote healthier food purchasing and dietary intake among pediatric cancer survivors and their families.

Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia

The goal of this study is to understand the development and progression of childhood dystonia, a movement disorder, in children. The main questions it aims to answer are: How does the activity of the neural network evolve in children with dystonia in the context of motor development? What are the effects of chronic and active stimulation on cortical and subcortical motor network function in children with deep brain stimulation (DBS)? Participants will: * Undergo noninvasive electrophysiological measurements (EEG, EMG) to quantify neural network activity. They will be tested at rest and during a simple motor reaction task. * Children with DBS will be assessed in the on and off DBS state to assess effects of chronic and active changes in motor network function.

Flexible Ureteroscopy Versus Mini- Percutaneous Nephrolithotomy in Management of Pediatric Renal Stones Less Than 2 cm

This single-center, prospective, two-arm randomized controlled trial included 58 patients younger than 18 years who were allocated 1:1 to Mini-PCNL or FURS between June 2023 and December 2024. The primary outcome was the six-week stone-free rate (SFR), defined as complete absence of residual fragments on postoperative imaging. Secondary outcomes included operative time, fluoroscopy time, hospital stay, auxiliary procedures, hemoglobin measurements, and postoperative complications.

Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis

The ALPACA-MC trial is a blinded, multicentre randomized controlled trial comparing two postoperative antibiotic treatments for children undergoing laparoscopic appendectomy for perforated appendicitis. Perforated appendicitis occurs when the appendix has developed a hole or has burst. The study will include 180 children from several pediatric hospitals. After surgery, participants will be randomly assigned to receive either piperacillin/tazobactam (PT) or ceftriaxone plus metronidazole (CM). The child, family, healthcare team, and researchers assessing the outcomes will not know which treatment was received. The main purpose of the study is to determine whether PT reduces hospital length of stay compared with CM. The study will also compare other important outcomes, including surgical site infections, the need for additional imaging or procedures, emergency department visits, and hospital readmissions. Children will be followed for 30 days after surgery. At 30 days, families will be contacted to ask about any additional complications and how well the child has recovered. This will include questions about returning to school, sports or other physical activities, and the child's overall health and quality of life. The results of this study will help determine which antibiotic treatment is most appropriate for children with perforated appendicitis and may help guide future clinical practice and antibiotic stewardship.

Pediatric Pilonidal Sinus Surgical Treatment

The aim of study to evaluate four different treatment options for pilonidal sinus disease in a randomized controlled trial to find the most suitable treatment option.

Quadratus Lumborum Block, Transversus Abdominis Plane Block, and Erector Spinae Block in Pediatric Abdominal Surgery

The aim of this study is to compare the analgesic efficacy and safety of Quadratus Lumborum (QL), Transversus Abdominis Plane (TAP), and Erector Spinae Plane (ESP) blocks in pediatric abdominal surgery.

Clinical Study of UC-MSC Combined With Immunosuppressive Agents in the Treatment of Pediatric HAAA

The goal of this clinical trial is to evaluate the effectiveness of umbilical cord mesenchymal stem cells combined with standard immunosuppressive therapy in children with HAAA, and to provide a new therapeutic idea for children with HAAA. Whether UC-MSC combined with immunosuppressants can improve outcomes in children with HAAA. Whether UC-MSC is safe in the treatment of children with HAAA. Participants will: 1 Age \< 18 years old, gender is not limited; 2 Diagnosis of hepatitis related aplastic anemia according to the criteria for hepatitis related aplastic anemia; 1. The patient has a history of acute prehepatitis, and the course of hepatitis is generally less than 6 months. The main clinical manifestations are fever, jaundice, anemia, bleeding, generally no liver enlargement. 2. Routine blood test: pancytopenia, HGB \< 100 g/L; Absolute neutrophil count \< 1.5×109/L; PLT \< 100×109/L (PLT reduction must be included in case of two-series reduction). Serum aminotransferase levels were elevated at least 200 U/L and hepatitis autoantibodies were negative. 3. Bone marrow aspiration and biopsy confirmed aplastic anemia. 4. Jaundice caused by other reasons and other pancytopenia diseases (such as congenital AA, clonal diseases and autoimmune diseases, etc.) are excluded. 3 No hematopoietic stem cell transplantation (HSCT); 4 The guardian and the subject will participate voluntarily and sign the informed consent;

Age Related Thresholds for Management of Severe Head Injury in Paediatrics: An Extension of STARSHIP

Traumatic brain injury in children can cause serious and long-lasting neuro-disability. However, there is still limited evidence about the best ways to treat children with severe brain injury in intensive care. One important part of treatment is managing pressure inside the skull and ensuring that the brain receives enough blood and oxygen. Current international guidelines provide treatment targets, but these recommendations are based on relatively limited research in children. This is particularly challenging because children range from infants to teenagers, and the developing brain changes considerably with age. A single treatment target may therefore not be appropriate for every child. Carrying out large clinical trials in critically ill children is difficult for both practical and ethical reasons. An alternative approach is to combine information that is already being collected during routine intensive care and use these large datasets to better understand which treatments may be most helpful. Investigator's previous multicentre study, STARSHIP (Studying Trends of Auto-Regulation in Severe Head Injury in Paediatrics), collected detailed information from 135 children with traumatic brain injury. The study combined clinical information with continuous measurements of brain-related physiology. One of these measurements, called the pressure reactivity index (PRx), provides information about how well the brain is able to regulate its own blood supply. Investigators found that PRx was associated with patient outcomes, regardless of the initial severity of the injury, and that treatment practices varying between hospitals. Investigators also found that changes in PRx over time may provide useful information about recovery and outcome. The STARSHIP study has created a valuable research database that allows us to explore how measurements such as pressure inside the skull, blood flow to the brain, and the brain's ability to regulate its blood supply relate to recovery. However, there were not enough children within each age group to determine whether different treatment targets should be used for infants, younger children, and teenagers. Several hospitals in the United Kingdom (UK) and internationally have collected similar detailed information. Through this project, these centres will work together to combine their existing datasets, creating a much larger group of approximately 350-500 children with traumatic brain injury. By analysing this larger dataset, investigators hope to identify treatment targets that are more appropriate for children of different ages. In particular, they will study pressure inside the skull, blood pressure supplying the brain, and the brain's ability to regulate its own blood flow. Ultimately, this research could help doctors move away from a "one-size-fits-all" approach and towards more personalised treatment for children with severe traumatic brain injury. By identifying age-appropriate and patient-specific treatment targets, investigators hope to improve brain protection and, ultimately, outcomes for injured children.

Two Different Videolaryngoscopes Were Used İn The Pediatric Patient Group

Modern alternatives to traditional laryngoscopes utilize fiber optic or digital technology to project images from the tip of the laryngoscope onto an eyepiece or monitor for improved visualization by the practitioner. Videolaryngoscopes have become an integral part of routine clinical practice and training programs, and a preferred option after failed DL (directional visualization). This study will compare two different videolaryngoscopes in pediatric participants.

Mini Percutaneous Nephrolithotomy and Retrograde Intrarenal Surgery for Pediatric Renal Stones (10-30 mm)

This work aimed to compare the safety and efficacy of retrograde intrarenal surgery using single-use flexible ureteroscopy (FURS) with mini-percutaneous nephrolithotomy (PCNL) in children with renal stones measuring 10-30 mm.

Reference Range Study for the Quantra System With the QPlus Cartridge in Pediatric Patients

This study will determine reference range intervals for the parameters reported by the Quantra System with the QPlus Cartridge in pediatric patients.

The Effects of Two Methods Applied on Pain and Fear During Phlebotomy in Children

Objective: This study aimed to evaluate the effects of using an externally vibrating dolphin-shaped Dolphin massage device and digital storytelling via tablet on pain and fear in children aged 3 to 6 years during blood collection. Method: This randomized controlled trial was conducted with 105 children aged 3-6 years who visited the pediatric blood collection unit of a training and research hospital between June 2024 and June 2025. This study used the CONSORT checklist. After obtaining consent from the child and parent, the children (n=105) were assigned to one of the groups (Dolphin massage device group (n=35), digital storytelling group (n=35), control group (n=35)) using block randomization. The children's pain and fear scores were assessed after phlebotomy by their parents, the nurse performing the phlebotomy, and the researcher using the Wong-Baker Pain Scale and the Child Fear Scale. The phlebotomy procedure was performed by a single nurse.

Study the Impact of the Mastoid and Middle Ear Volume on the Success of Type 1 Tympanoplasty in Pediatric Age, With Comparing Using Cartilage and Fascial Grafts Through This, Strength the Hypothesis of That Total Tympanometry Volume Correlates With Ventilated Mastoid Air Cells Volume on CT Scans

The goal of this observational study is to know the impact of the mastoid and middle ear volume on the success of type 1 tympanoplasty in pediatric age, with a closer view on the comparison of using cartilage and fascial grafts through this. The investigators also hoping to strength the hypothesis of that total tympanometry volume correlates with ventilated mastoid air cells on Computed Topography (CT) scans that allow us to predict a well-ventilated mastoid air cell system. This may help reduce the need for pre-operative CT scans in uncomplicated cases with tympanic membrane perforations. The main question it aims to answer is: Does Mastoid ventilation affect the success of tympanoplasty (Type 1) in pediatric age group? and which graft is better and if the tympanometry volume (non invasive investigation) correlate with the degree of the mastoid pneumatization degree and volume (based on CT scan and 3D volumetric measuring). Participants already taking intervention a as part of their regular surgical treatment of chronic suppurative otitis media with perforation in the form of Type 1 tympanoplasty (Myringoplasty), informed consent was obtained from all the study participants guardians. Regular postoperative follow up of the success rate (structural success was evaluated 1 month postoperatively) and functional success were evaluated at 1.5 months and 3 months postoperatively.

New Cases of EoE in Children in Poland.

The aim of the study is to assess the incidence of EZP in Poland in the pediatric population and characteristics of Polish patients with EZP, i.e. their demographic, clinical, endoscopic and histological features. Another important objective of the study is to identify areas where the diagnosis and treatment of EZP in children can be improved. The study is prospective and non-interventional.

Posıtıve Psychology-Based Art Therapy In Hospıtalızed Chıldren

Pediatric hospitalization is known to be associated with negative developmental and psychosocial outcomes for child patients. Art therapy is a way to directly address the emotional world of hospitalized children. This research is significant both scientifically and clinically as an innovative intervention aimed at reducing the negative effects of pediatric hospitalization on the psychosocial and emotional development of children. It is believed that the research will contribute to a holistic approach to nursing care and lead to the development of scientifically based interventions in clinical practice. Furthermore, this research will provide nurses with evidence-based information that can guide them in implementing and evaluating self-compassion and empathy-focused care strategies that support children's psychosocial well-being. In this respect, the research directly contributes to nursing practice and provides transferable outcomes. This research was planned to examine the effect of positive psychology-based art therapy on self-compassion and hope levels in children aged 8-12 years hospitalized in a pediatric ward. The research will be conducted as a single-blind, randomized controlled experimental study with a pre-test, post-test design at Süleyman Demirel University Research and Application Hospital between June and December 31, 2026. Prior to the research, permission will be obtained from the scale administrators, participants, parents, ethics committee, and the institution. The sample will consist of 80 individuals (40 in the intervention group and 40 in the control group) who meet the inclusion criteria, are selected using simple randomization, and provide informed consent. The control group will receive no intervention; the pre-test will be administered on the first day, and the post-test on the day the intervention for the experimental group ends. The intervention group will receive art therapy three days a week for a total of five sessions; the pre-test will be administered on the first day, and the post-test on the last session. Data will be collected using the Personal Information Form (PIF), the Children's Hope Scale (CHS), and the Children's Self-Compassion Scale (CSCS). Data will be analyzed using the SPSS (Statistical Program for Social Sciences) statistical analysis software package, and statistical significance will be accepted as p \<0.05.

A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Evaluation of the Effectiveness of Enhanced Recovery After Surgery (ERAS) Program in Pediatric Lung Surgery

This study aims to evaluate the clinical effectiveness of the Enhanced Recovery After Surgery (ERAS) program for pediatric lung surgery at our institution.

Improving Pediatric Nursing Undergraduate Education: An Escape Room on Dehydration in Children

Nursing education aims to equip students with the knowledge, skills, attitudes, and behaviors required for safe and effective professional practice. However, traditional teacher-centered approaches are often insufficient for developing competencies such as critical thinking, problem-solving, decision-making, communication, and teamwork.Consequently, innovative student-centered teaching strategies are increasingly being integrated into nursing education.Game-based learning is one such strategy that enhances engagement, motivation, active participation, and collaborative learning. Among GBL approaches, the educational escape room combines gamification with problem-solving by requiring students to work collaboratively under time constraints to solve realistic clinical scenarios. This method promotes active learning while strengthening communication, teamwork, leadership, and clinical reasoning skills. Educational escape rooms have been successfully implemented in several areas of nursing education, including women's health, pediatric care, geriatric nursing, cardiovascular diseases, clinical skills, teamwork, and leadership. Despite these developments, evidence regarding their use in pediatric nursing education remains limited.Dehydration is one of the most common pediatric health problems and requires nurses to accurately assess hydration status, recognize clinical findings, and implement appropriate nursing interventions. Competence in dehydration management is therefore essential for pediatric nursing students. To date, no published study has evaluated an educational escape room designed specifically to teach pediatric dehydration management. This study aims to examine the effectiveness of an educational escape room implemented during a pediatric nursing laboratory simulation on nursing students' hydration knowledge, teamwork, and anxiety levels. It is expected that this innovative educational approach will enhance students' knowledge acquisition and teamwork skills while reducing anxiety during learning.

Pain and Anxiety During Vital Pulp Therapy Using Different Local Anesthesia Techniques in Children

This prospective observational study aims to evaluate the effects of different local anesthesia techniques on dental anxiety and pain in children undergoing vital pulp therapy of permanent mandibular first molars. Conventional inferior alveolar nerve block and two computer-controlled local anesthetic delivery (CCLAD) systems used in routine clinical practice will be compared. The choice of anesthesia technique will be based on the clinician's routine decision-making, and no additional intervention or modification of standard treatment will be performed for research purposes. Dental anxiety, pain, physiological parameters, and postoperative complications will be assessed using validated clinical scales and routine clinical measurements. The findings may help improve pain and anxiety management during pediatric dental treatment while supporting evidence-based selection of local anesthesia techniques.

Sedation Safety Assessment Using IPI Monitoring in Pediatric Hematologic Procedures

Pediatric hematologic procedures such as lumbar puncture and bone marrow aspiration often require deep sedation due to pain and the need for immobility. Sedative and opioid combinations increase the risk of respiratory depression. Integrated Pulmonary Index (IPI) combines SpO₂, EtCO₂, respiratory rate, and heart rate into a single score and may allow earlier detection of respiratory compromise. This study aims to evaluate the safety and effectiveness of IPI monitoring in pediatric patients undergoing hematologic procedures under sedation with BIS monitoring.

AI-Generated Maternal Voice Storytelling During Pediatric Adenotonsillectomy

This prospective, three-arm randomized controlled trial aims to evaluate the effects of AI-generated maternal voice storytelling on the perioperative stress response, emergence delirium, anesthetic requirements, and perioperative physiological parameters in children undergoing elective adenotonsillectomy. Participants will be randomly assigned to receive AI-generated maternal voice storytelling, relaxing instrumental music, or standard perioperative care. Standardized anesthesia protocols will be used in all groups, and perioperative outcomes will be compared among the three study arms.

The ED95 of Ciprofol for Laryngeal Mask Airway Insertion With Fentanyl in Children: A Biased-Coin Dose-Finding Trial

Ciprofol is a novel intravenous anesthetic with a pharmacological profile similar to propofol but with a lower incidence of injection pain, hypotension, and respiratory depression. For pediatric day-case surgeries, laryngeal mask airway (LMA) insertion without neuromuscular blockers is increasingly preferred. While opioids are often combined with hypnotics to optimize insertion conditions, the optimal bolus dose of ciprofol when co-administered with a standard dose of fentanyl for LMA insertion in children remains unknown. This study aims to determine the 95% effective dose (ED95) of a single intravenous bolus of ciprofol, combined with a fixed dose of fentanyl (1 μg/kg), for successful LMA insertion in children aged 1-12 years during general anesthesia induction.

Use of the Single Port Robotic System in Pediatric Surgery

Open surgery (laparotomy) has long been the gold standard for pediatric surgery. The development of laparoscopy in the 1980s reduced post-operative pain. Since the 2000s, robotic surgery has been on the rise. The most commonly used robotic system is the Xi robotic system (Intuitive Surgical), which allows instruments to be inserted through three or four trocars and replicates the movements of the surgeon's hands as they sit at a control console a few meters away from the patient.The Single Port (SP) robotic system is a new development in this technology. It allows the same procedures to be performed using a single trocar instead of four. CE marking was obtained in 2024 for abdominal surgery, but without provision for use in children. The pediatric surgery team at Saint-Etienne University Hospital has been performing robotic surgery using the Xi (Intuitive) system since January 2020. Between January 2020 and April 2025, 150 patients underwent surgery, including 49 pyeloplasties, 42 ureterovesical reimplantations, and 23 gastroesophageal reflux treatments. No conversions were necessary, and there were no complications related to the use of the robotic system. The Saint-Etienne University Hospital was the first institution in France to acquire the SP robotic system.

Fast Brain MRI in Children With Suspected Brain Tumor

This study aims to assess the diagnostic performance of a new fast MRI sequence named Neuromix compared to routine clinical MRI for brain tumor in pediatric patients