Clinical Research Directory

Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function

Hematopoietic stem cell transplantation (HSCT) is a potentially life-saving treatment for children with relapsed or resistant leukemia and other life-threatening hematological and hereditary disorders. In Denmark, around 25 children undergo allogeneic HSCT every year, of these approximately 85-90% survive into adulthood. The goal of this observational study is to learn about neurocognitive outcomes in children undergoing (HSCT) and to understand which clinical, physical, and environmental factors may affect neurocognitive development during the first year after transplant. The main questions it aims to answer are: How does neurocognitive function change from before HSCT to one year after transplantation in pediatric patients? Which clinical, physical, and environmental factors are linked to better or worse neurocognitive outcomes? Participants will: Complete neurocognitive tests before HSCT and at 1-year follow-up, covering intelligence, memory, attention, executive function, processing speed, and motor skills. Undergo physical tests before HSCT, at hospital discharge, at 6-months follow-up, and at 1-year follow-up, including muscle strength, mobility, endurance, balance, and cardiopulmonary fitness (only at 1-year follow-up). Wear activity trackers to measure physical activity and sedentary time during hospitalization at 6 months and 1-year post-HSCT. Complete questionnaires about sleep, pain, quality of life, fatigue, family background, and exposure to outdoor and green spaces. Have medical records reviewed for treatment-related side effects, immune recovery, inflammation, and pain management. This study will help understand how neurocognitive function develops after HSCT in children and which factors (clinical, physical, or environmental) may support better recovery and well-being.

Preoperative Gamified Breathing Exercise on Anxiety and Delirium in Children.

This study aims to evaluate the effect of preoperative gamified breathing exercises on preoperative anxiety and postoperative emergence delirium in children. The intervention includes games like ball blowing and bubble blowing. Anxiety is measured using the mYPAS-SF scale, and delirium is assessed with the PAED scale.

Impact of Conversational Approaches in Pediatric Social Robot-Mediated Interventions

This study examines how different robot dialogue systems (rule-based vs. large language model-based) and content types (emotional support vs. safety education) affect pediatric patients' responses during hospital-based robot-mediated interventions. Approximately 60 pediatric patients aged 2-9 years will be randomly assigned to interact with a social robot (LIKU) using either rule-based or LLM-based dialogue. Each child will participate in two activity sessions (emotional content and safety content) in randomized order. Primary outcomes include child engagement, emotional responses, robot perception, and activity preferences, assessed through standardized questionnaires (UEQ, Godspeed), child interviews, and behavioral observations. Additionally, 5 experts will evaluate content appropriateness and safety. This pilot study aims to provide foundational data for developing personalized pediatric robot programs in hospital settings, optimizing both dialogue approaches and content design based on individual child characteristics.

Sweet-Tasting Solution Versus Placebo to Reduce Pain During Local Anesthetic Injection in Children

The goal of this clinical trial is to learn whether applying a sugar-free flavored sweet solution (SFSS) before local anesthesia helps reduce injection pain in children. The main question it aims to answer is: Does SFSS reduce pain during dental local anesthesia compared to a placebo (plain water)? Researchers will compare the use of SFSS and a placebo to see which results in lower pain scores. Participants will: Receive SFSS or placebo before local anesthesia during two dental visits Have their pain measured using self-reported and observational pain scales Have their heart rate monitored during the procedure

To Assess the Efficacy of Carica Papaya Leaf Extract in Improving Platelet Counts Among Pediatric Patients With Dengue-associated Thrombocytopenia

The goal of this clinical trial is to evaluate whether Carica papaya leaf extract (CPLE) can improve platelet counts in children aged 2 to 12 years diagnosed with dengue fever and thrombocytopenia. The main questions it aims to answer are: Does Carica papaya leaf extract significantly increase platelet counts compared to standard supportive therapy alone? Does the use of Carica papaya leaf extract reduce the need for platelet transfusion or PICU admission? Researchers will compare the group receiving CPLE plus standard therapy to the group receiving standard therapy alone to see if CPLE leads to improved platelet recovery and better clinical outcomes. Participants will: Be randomly assigned to receive either standard care or standard care plus Carica papaya leaf extract syrup (10 mL orally, three times daily for 3 days) Undergo blood testing on Day 1 and Day 3 to assess platelet count, hemoglobin, WBC, and packed cell volume Be monitored for clinical outcomes including need for transfusion and admission to the Pediatric Intensive Care Unit (PICU)

Ultrasound Guided Bilateral Pectoral Nerve Block Versus Bilateral Transverse Thoracic Plane Block In Pediatric Patients Undergoing Corrective Cardiac Surgeries Requiring Cardiopulmonary Bypass Via Median Sternotomy

This randomized, double-blinded, study aims to compare the efficacy of intraoperative and postoperative pain control while using bilateral ultrasound guided the pectoral nerves (PECS) versus transversus thoracic muscle plane block (TTPB) in pediatric patients undergoing corrective cardiac surgeries.

Nociception Level Index as a Verbal Tool of Pain in Children

60 children under 6 years old, scheduled for orthopedic surgery for limb fracture or neuromuscular and bone deformities will be randomized by closed envelope method into two groups (n=30) either receiving standard pain management protocol or intraoperative NOL guided analgesia. Our study aims to evaluate the nociception monitor's effectiveness in providing adequate postoperative analgesia in pediatric patients. Besides, the difference between the amount of analgesic medication will be recorded. Data to be recorded are total intraoperative morphine and postoperative rescue analgesic consumption, NOL values, and FLACC scores.

Virtual Reality Distraction in Pediatric Patients.

The aim of this study is to evaluate the effect of virtual reality distraction on pain and anxiety during infiltration anesthesia in pediatric patients.