Clinical Research Directory

Observation Periods and Biphasic Reaction Risk Factors in Pediatric Emergency Anaphylaxis Cases

This study reviews the medical records of children who presented to the pediatric emergency department of Adnan Menderes University Hospital with a diagnosis of anaphylaxis between January 2014 and December 2024. The aim is to determine how long children were observed in the emergency department, how often biphasic reactions (a second wave of symptoms) occurred, and which risk factors (such as delayed adrenaline use or asthma) may increase this risk. The results will help improve the care of children with anaphylaxis and guide recommendations for safe observation times.

Exercise as Medicine for Pediatric Chronic Pain

Youth with chronic pain struggle to go to school, play sports, or spend time with friends and family due to pain. Medications are often ineffective, and aerobic exercise may improve both pain sensitivity and participation in valued life activities. This study will be the first to examine the impact of a single session of intense aerobic exercise on pain sensitivity measures in youth with and without chronic pain syndromes to help determine if aerobic exercise can improve pain and functioning.

Child Behavior Ratings During Dental Treatment

This is a descriptive observational study aimed at evaluating the inter-rater agreement of four behavioral rating scales used in pediatric dentistry-the Houpt Scale, the Ohio State University Behavioral Rating Scale, the Venham Scale, and the Frankl Scale-for assessing children's behavior during dental treatment. The study will be based on the analysis of video recordings of clinical procedures. The study will include 30 children aged between 4 and 10 years who attend the Pediatric Dentistry postgraduate training clinic at the University of Valencia for dental treatment. Only children whose parents or legal guardians have signed the informed consent form for participation in the study, the consent form authorizing the dental treatment, and the consent form authorizing the use of images will be included. Children classified as ASA III or IV, children with neurological or cognitive disorders, and children whose parents do not agree to participation or do not sign the informed consent form will be excluded. Clinical situations in which video recording could interfere with the safety of the procedure or compromise the patient's well-being will also be excluded. The dental treatment will be performed by students enrolled in the postgraduate program in Pediatric Dentistry and will consist of restorative treatment for dental caries requiring local anesthesia.

"AFRONTA Emotional Care" Intervention for Family Caregivers of Children With Cancer.

The objective of the protocol is to evaluate the acceptability and feasibility of "AFRONTA Emotional Care" to reduce caregiver burden in family caregivers of children with cancer at a children's cancer foundation in Pachuca, Hidalgo, Mexico. The main questions to be answered are: * What is the acceptability and feasibility of "AFRONTA Emotional Care"? * Does the AFRONTA Emotional Care intervention reduce caregiver burden in family caregivers of children with cancer? The researchers will * Implement a series of therapeutic sessions based on a dialogue circle where * They will guide specific objectives related to caregiver burden characteristics * They will administer a questionnaire before and after the sessions to evaluate the results The participants will * Sign informed consent * Attend the dialogue circle sessions * Develop exercise-based activities that promote active listening, respect, and empathy. * Wait your turn to speak and speak up (converse) * Promote the collective development of ideas and the resolution of care-related conflicts.

AI-Generated Video Distraction Via Virtual Reality for Fear and Pain During Pediatric Circumcision

This randomized controlled trial evaluated the effect of artificial intelligence-generated video distraction delivered via virtual reality on procedural fear and pain in children undergoing circumcision. A total of 80 children aged 4-12 years were assigned to an intervention group (n=40) or a control group (n=40). Children in the intervention group received AI-generated video distraction via virtual reality, whereas children in the control group received routine care. Pain and emotional responses were assessed from the perspectives of the child, parent, and nurse. Physiological parameters were also measured before and after the procedure. The study aimed to determine whether AI-generated video distraction delivered via virtual reality reduces procedural fear and pain during pediatric circumcision.

Clinical Effectiveness of the "PICU Up!" Multifaceted Early Mobility Intervention for Critically Ill Children

While mortality in U.S. pediatric intensive care units (PICUs) is improving, surviving children frequently develop persistent physical, cognitive, and psychological impairments. Over half of critically ill children experience potentially preventable PICU-acquired morbidities, with mechanically ventilated children being at greatest risk. In critically ill adults, randomized trials have shown that progressive mobility, started early (within 3 days of initiating mechanical ventilation), decreases muscle weakness and the duration of mechanical ventilation. However, similar randomized studies have not been conducted in the PICU. The investigator's prior studies revealed that less than 10 percent of critically ill children at the highest risk of functional decline are evaluated by a physical or occupational therapist within 3 days of PICU admission. Given the interplay of sedation, delirium, sleep, and immobility in the PICU, single-component interventions, such as sedation protocolization, have not consistently shown benefit for decreasing mechanical ventilation duration. Thus, the investigators developed the first pediatric-specific, interprofessional intervention (PICU Up!) to integrate goal-directed sedation, delirium prevention, sleep promotion, and family engagement into daily PICU care in order to facilitate early and progressive mobility. The investigators have demonstrated the safety and feasibility of this pragmatic, multifaceted strategy in both single-site and multicenter pilot studies. Hence, the next phase of the investigators research is to evaluate the clinical effectiveness and delivery of the PICU Up! intervention across a range of PICU patients and health systems. The investigators propose a pragmatic, stepped-wedge, cluster randomized controlled trial that will include 10 academic and community hospitals in the United States, with the following Aims: 1) Evaluate if the PICU Up! intervention, delivered under real-world conditions, decreases mechanical ventilation duration, measured as days alive and ventilator-free (AVF) through Day 21 (primary outcome) and improves delirium and functional status compared to usual care in critically ill children; and 2) Conduct a multi-stakeholder, mixed-methods process evaluation to identify key contextual factors associated with delivery of PICU Up!. If proven effective, the PICU Up! intervention has potential to profoundly change medical care in the PICU and substantially impact public health by improving outcomes for the growing number of pediatric survivors of critical illness.

Core Stability, Functional Capacity, Balance, Strength, and Fatigue in Pediatric Demyelinating Diseases

This study aims to evaluate balance ability, core stability, functional capacity, lower extremity muscle strength, and fatigue levels in children diagnosed with central nervous system demyelinating diseases, in order to contribute to the development of evidence-based and individualized rehabilitation strategies.

Health Benefits of Air Purifiers in Primary School Students

This study aims to explore changes in cardiopulmonary function and other health indicators in primary school students with the intervention of air purifiers on a randomized controlled trial.

Guardians Receiving Information Through Navigators

A multi-arm study, experimental and control groups, to explore the impact of an online training program to help community health workers conduct effective outreach to support the dental health of high-risk youth via their guardians.

Effectiveness of the Sleep Island WeChat Mini-Program for Promoting Sleep in Preschool Children

Behavioral sleep problems are common during the preschool years and are strongly influenced by parental sleep-related practices and the home environment. This randomized controlled trial aims to evaluate the effectiveness of Sleep Island, a parent-focused WeChat mini-program adapted from a theory- and evidence-based parent-child collaborative behavioral sleep promotion program. A total of 122 families with preschool children will be randomly assigned in a 1:1 ratio to either the Sleep Island intervention plus routine sleep-health education or a waitlist control condition receiving routine sleep-health education. The intervention will be delivered over 4 weeks. Sleep Island incorporates electronic sleep monitoring, visualization of sleep patterns, individualized sleep-behavior feedback, sleep-health education, and personalized behavioral recommendations. Recommendations are generated using a large language model supported by retrieval-augmented generation from a curated pediatric sleep knowledge base and are reviewed by the research team before release. Outcomes will be assessed at baseline, immediately after the intervention, and at 3- and 6-month follow-up. The primary outcome will be objectively measured child nocturnal sleep duration. Secondary outcomes will include other objective and parent-reported indicators of child sleep health, parental sleep-related practices, sleep environment, behavioral sleep problems, and parental knowledge, attitudes, self-efficacy, and beliefs regarding child sleep.

The Role and Awareness of Mothers in Home Accidents Among Children Aged 0-3

When considering developmental stages, children are the most vulnerable, the most in need of care, and the ones who require the most affection. The overall well-being of children is crucial for the development of the society in which they live. Children, who are influenced by physical, social, and cultural conditions, are particularly exposed to various accident risks, especially in the home environment. Children in the 0-3 age group, who spend most of their time at home, constitute the group with the highest accident rate due to their curiosity about exploring their surroundings, their constant movement, their lack of experience with dangers and risks, their tendency to imitate adults, and their insufficient development of the skills needed to protect themselves from accidents. Research indicates that numerous factors contribute to the occurrence of home accidents involving children. The child's age, gender, the family's socioeconomic status, the parents' educational background, and environmental factors play a decisive role in the occurrence of these accidents. It is the parents' responsibility to protect the child from any potential risks. By understanding the physical and mental developmental stages appropriate for the child's age, parents can anticipate and prevent potential hazards and unsafe situations. Mothers, who are primarily responsible for the care of children, play a key role in preventing home accidents. A mother's educational level, perception of accidents, and level of knowledge on the subject directly influence the child's risk of exposure to accidents. The safety measures mothers take regarding home accidents are a decisive factor in reducing the risks children may face within the home. While studies on home accidents exist in the literature, they are not sufficiently comprehensive. The aim of this study is to determine the frequency of home accidents among children aged 0-3 and the factors associated with these accidents; to evaluate mothers' attitudes and behaviors regarding this issue; and to identify potential risks. This study will serve as a guide in determining the extent to which mothers' awareness and the safety measures they implement for children aged 0-3 who have experienced home accidents influence the frequency of such accidents.

Robotic and Aquarium Fish for Reducing Pain, Fear, and Anxiety in Children

This study aims to find out whether robotic fish and aquarium fish can help reduce pain, fear, and anxiety in children during painful medical procedures. The main questions this study aims to answer are: Does watching robotic fish during a painful procedure reduce children's pain, fear, and anxiety? Does watching aquarium fish during a painful procedure reduce children's pain, fear, and anxiety? Are there differences in pain, fear, and anxiety between children receiving these interventions? During the painful procedure, children in the intervention groups will watch either robotic fish or aquarium fish as a distraction. Children's pain, fear, and anxiety levels will be assessed using age-appropriate measurement tools. Researchers will compare the results between the study groups to determine whether robotic fish or aquarium fish can help children feel more comfortable during painful medical procedures. The findings may provide information about simple, non-drug methods that nurses and other health care providers can use to help reduce children's negative experiences during painful procedures.

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety: : Randomize Controlled Study

It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety. Hypothesis: Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group. Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group. Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group. Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.

Breaking Disparities in Access to Advanced Diabetes Technologies in Children With Type 1 Diabetes

50 children/adolescents (ages 6 to \<18yrs) with T1D in suboptimal control (HbA1c≥8.0%) and lower SES (below 200% poverty line) on insulin therapy (either injections or open-loop pumps) will be recruited at Nemours \~ 1/3 each AA, Hispanic/Latino, non-Hispanic whites. All families that qualify and agree to transition to closed-loop technologies will be recruited to allow data to be gathered before and after use of devices. They will go through the process of approval with the assistance of an insurance navigator in clinic. Those not a CGM will be prescribed one as well. Diabetes care will be 'real life', devices will be prescribed, and care per clinic routine with periodic device downloads. Principal outcome, time-in-range, will be analyzed at 3-months compared to baseline, each participant their own control. Secondary outcomes including HbA1c, other glucose metrics and questionnaires related to use of technology and diabetes distress will be also analyzed. All outcomes will also be collected at 6-months. Results could have important and fast applicability to the field and help better inform decision makers, including payers, clinicians, and patients and families and could serve to decrease health care disparities in this needy population.

Family Lifestyles, Actions, and Risk Education Intervention: Version 2

The overall purpose of this study is to determine the efficacy of the Family Lifestyles, Actions, and Risk Education (FLARE) intervention in improving melanoma preventive behaviors. Parent-child dyads, consisting of survivors of melanoma and their children, will be randomly assigned to either receive the FLARE intervention or standard education. Once enrolled, each parent-child dyad will participate in this study for just over 1 year. Both conditions will receive three bi-weekly live intervention sessions (30 minutes per session) with an interventionist, and quarterly boosters via text or email.

Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age

In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. These assessment situations are not representative of the functional difficulties encountered by people with hearing loss or Auditory Processing Disorder in their daily lives. In real life, "soundscapes" are diverse. Hearing assessment and rehabilitation should include the child's everyday environments as well as their lifestyle habits. The Immersion 360 System (Virtual reality system) was developed specifically to virtually reproduce complex everyday sound experiences with realistic noise types and sound presentation conditions, enabling the assessment of auditory perception under test conditions similar to those encountered in daily life. Some of the sound environments offered by this innovative system have been standardized for adults. No standards exist for children, and we have limited knowledge regarding the development of speech perception skills in noise during childhood and adolescence. It seems essential to measure the age-related development of speech perception in realistic sound environments in order to establish reference data for children and adolescents. This work will, through functional assessments of the auditory system and linguistic tests (speech perception in noise), provide a better understanding of the functional development of the central auditory system for speech perception in noise. The results collected from normo-hearing individuals in the age groups of interest will provide a clinical baseline for comparison with patients of the same age.

Conmigo: A Mother-daughter Intervention to Promote Physical Activity

Regular physical activity (PA) contributes to reduced risk of obesity, chronic disease, cardiovascular disease, and cancer, and can improve emotional and mental health, learning, productivity, and social skills. Latina girls are less likely to meet guidelines for moderate-to-vigorous physical activity (MVPA) than non-Hispanic white girls; factors that contribute to low PA rates among Latina girls include sex role expectations, low PA competency, few active role models, lack of parental support for PA, and lack of access to resources. The goal of this study, informed by social cognitive theory and family systems theory, is to design, implement, and evaluate an intervention promoting physical activity among Latina pre-adolescent girls (aged 8-11) and their mothers. The intervention is based on evidence suggesting that parent-child interventions and single-sex interventions are more effective at improving PA. Mothers and daughters will participate in a 12-week virtual intervention where they will engage in weekly 1.5-hour sessions that incorporate didactic teaching, skill-building, interactive discussions, and PA. Each session will include at least 30 minutes of PA. The intervention will be compared with a control condition that will receive an abbreviated version of the intervention following completion of all measurement points. Ninety mother-daughter dyads will be randomly assigned to the intervention or the wait-list control condition. The primary aim is to determine whether the intervention will increase MVPA among Latina girls in the intervention condition relative to those in the control condition. The investigators hypothesize that daughters participating in Conmigo will have higher minutes of MVPA at M2 and M3 compared to girls in the delayed treatment control condition.

Thoracic Mobility, Posture, Functional Capacity, and Respiratory Rate in Children Playing Wind Instruments

The aim of this study is to evaluate thoracic mobility, posture, functional capacity, and respiratory rate in children aged 8-14 years who play wind instruments and to compare these findings with those of their peers who do not play wind instruments. In line with this primary objective, the study seeks to comprehensively investigate the potential biomechanical and physiological adaptations associated with playing wind instruments in the context of childhood music education, with a particular focus on chest wall mobility, postural alignment, respiratory efficiency, and functional capacity. The novelty of this study lies in being the first to adopt a holistic perspective to examine the effects of wind instrument playing on the postural and cardiorespiratory systems during the sensitive developmental period of 8-14 years, which is known to be highly responsive to biomechanical adaptations. By addressing this understudied age group, the study aims to fill an important gap in the existing literature.

Impact of Forced Expiration On Pleural Drainage Duration (KPDP)

Following thoracic surgery, pleural effusion in pleural cavity requires post-operative drainage. Pleural effusion is responsible for pulmonary congestion, atelectasis, hypoventilation, lower efficacy of diaphragmatic curse, lower pulmonary reexpansion and vicious attitude. These complications could be avoided by respiratory physiotherapy. Forced expiration technic in ipsilateral decubitus is one of these technics but has never been proved better than other technics regarding its efficiency. The aim of the study is to compare the impact of such a technic on post operative thoracic drainage after pulmonary, pleural or mediastinal pediatric surgery.

Assessment of Intestinal Inflammation by Infrared Thermography in Pediatric Crohn Disease

The assessment of digestive inflammation and disease activity in paediatrics Crohn's disease (CD) is currently based on anamnestic, clinical and paraclinical elements such as the paediatric CD activity index (wPCDAI) , faecal calprotectin measuring or digestive endoscopy. Infrared thermal imaging is based on capturing electromagnetic waves, on a specific Wavelength, emitted by the human body surface and representing local thermic-metabolic activity. It concern metabolic activity in digestive inflammations. Infrared imaging is a non-invasive, contactless, stressless technique that assess the variations in skin surface temperature of the patient's entire abdomen or more targeted areas in a single photography. This technique would be useful for determination of Crohn's disease activity, inflammation's degree and partial mapping of inflammatory lesions. In a specific room with a patient lying, the investigators will determine the abdominal infrared radiation with a FLIR® thermal camera. This will be correlated with the measurement of the faecal calprotectin concentration and the composite CD activity index wPCDAI. All measurements will be performed during the standard follow-up of Crohn disease. No additional follow will be necessary.

Strengthening Children's Coordination and Balance in Everyday Life

The World Health Organization recommends that children and teenagers aged 5 to 17 should be physically active for at least 60 minutes every day. This should include activities that make them breathe harder, as well as exercises that strengthen muscles and bones. National guidelines in Austria and Germany also highlight the importance of basic movement skills such as endurance, strength, coordination, and balance. Regular physical activity is important for children's physical and mental health. It can help prevent problems such as obesity, diabetes, and heart disease. It can also support learning, concentration, and school performance. However, many children do not move enough. In Austria and Germany, only a small number of children and teenagers meet the recommended activity levels. Because of this, many programs have been created to encourage children to be more active, for example through active breaks, park activities, or sports clubs. These programs often include simple movement games, warm-up exercises, and strengthening exercises such as squats. Balance and coordination exercises are used less often. Also, many programs mainly count how many children take part, but they do not always measure how the programs improve children's movement skills. This study therefore looks at whether targeted balance and coordination training improves the motor skills of children aged 6 to 11 in school sports. It will compare this training with strength training. Over four weeks, children will take part in one of the two training programs. Their motor skills, such as coordination, strength, flexibility, and endurance, will be tested before and after the program. The study will also look at how the children's general physical activity level influences their motor development.

Outpatient Pediatric Pulse Oximeters in Africa

The primary objective of this clinical trial is to evaluate the performance of three pulse oximeters during outpatient care within Cape Town, South Africa. This objective will be achieved through generating evidence on how, why, for whom, to what extent and at what cost can paediatric pulse oximetry devices improve the management of hypoxemic children. This will be done with two inter-linked studies: * Aim 1: Determine the impact of two novel paediatric pulse oximeter devices on the correct management of hypoxaemia. * Aim 2: Describe the burden of hypoxaemia and risks for mortality amongst children presenting with acute respiratory infections in a low-resource setting in Cape Town.

The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences. In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure. Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter. The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.