Clinical Research Directory

Mucoadhesive Gels in Controlling Gag Reflex Among Children During Dental Radiographic Examination

This randomized clinical trial compares tannic acid-zinc acetate mucoadhesive gel with lidocaine gel for reducing gag reflex in children aged 8-10 years during radiographic dental examination Gag reflex severity and pulse rate will be assessed before and after gel application. The study evaluates the effectiveness of the tested gel as a potential alternative to lidocaine.

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.

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.

Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PET/CT Assessment

Generally, pediatric patients tolerate acute toxicities but are vulnerable to late effects. Thus, increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing. In this CCCG-HL-2024 study, Brentuximab vedotin (Bv) was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study, respectively, to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma (cHL) in children, adolescents and young adults. On the premise of maintaining a 4-year event free survival (EFS)\>90% in the low-, intermediate-and high-risk groups, increase the early assessment complete response rate (the overall early complete response rate increased by 20%, that is, from 54.0% to 74.0%) to further reduce the proportion of children receiving radiotherapy to benefit them.

The Behavioral Effects of Mindfulness-Based Technology Use Training in Preschool Children

With the rapid advancement of technology, the use of digital devices has become widespread even in early childhood. While the conscious and controlled use of technology in the preschool period can contribute to children's development, prolonged and uncontrolled screen use can lead to various negative consequences such as sleep problems, attention issues, increased anxiety levels, and difficulties in social relationships. In particular, exposure to violent media content can cause children to perceive the world as more frightening and experience anxiety. Mindfulness-based training supports individuals in directing their attention to the present moment, recognizing their emotions, and accepting their experiences without judgment. Such training is known to develop self-regulation, attention, and emotional awareness skills in children. The purpose of this study is to examine the effect of mindfulness-based technology use training applied to preschool children on their media usage habits, sleep patterns, fear levels, and parent-child relationship. The study is planned as a randomized controlled trial with an experimental design. The intervention group will receive mindfulness-based technology use training, while the control group will receive no intervention. The study expects that mindfulness-based training will reduce children's screen time, improve sleep quality, decrease fear levels, and strengthen parent-child relationships. This study aims to contribute to the development of intervention programs that support healthy technology use in early childhood.

Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)

This study aims to see if mobile video clips (smartphone recordings) can be used to screen children with Down syndrome to identify those at highest risk of obstructive sleep apnea (OSA), so they can be prioritized for an earlier sleep study. Parents will be asked to record short video clips of their child sleeping, and then rate whether they think their child has OSA. Later, children will undergo a sleep study to compare to the ratings.

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 (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.

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.

The Effect of Supporting the Incision Site With Toys During Mobilization in Children Aged 4-10 Years Undergoing Abdominal Surgery

Aim: The aim of this study is to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Method: The study was a randomised controlled trial. The study sample consisted of 74 children (Toy: 37, control: 37) who has undergone abdominal surgery between March 2026 and December 2026 at the Mersin University Hospital Pediatric surgery department. The data collection tools used will be the Children Information Form, Wong Baker Pain Scale , Fear scale. In the intervention group, toy will be used after surgery, while the control group will receive routine care. The chils' pain and fear levels will be assessed by the nurse before and after the procedure.

Hemoglobin Levels and Resolution Time of Diabetic Ketoacidosis in Pediatric Patients

This retrospective observational cohort study aims to evaluate the association between hemoglobin levels and the time to resolution of diabetic ketoacidosis (DKA) in pediatric patients. The primary hypothesis is that children with anemia experience a longer duration of DKA and prolonged hospitalization compared with non-anemic children. All eligible patients aged 1-18 years who were diagnosed with DKA between 01.01.2013 and 01.01.2025 at a tertiary pediatric center will be included. Clinical, laboratory, and treatment data will be collected from electronic medical records.

Melatonin vs Midazolam in Children Undergoing Tonsillectomy

Used as a premedication to decrease anxiety (Caumo et al., 2007). Midazolam, though has several drawbacks (McCann and Kain, 2001). Hence, an alternative premedication to midazolam will definitely have a widespread appeal. Melatonin is a hormone secreted by the pineal gland. Melatonin is different from benzodiazepines and their derivatives in that it exerts a promoting effect on sleep by amplifying day/night differences in alertness and sleep quality and displaying a modest sleep-inducing effect, quite mild as compared to that seen with benzodiazepines (Ahmad et al., 2007). Melatonin has also been reported to cause preoperative anxiolysis and an increase in levels of sedation without impairing orientation (Naguib and Samarkandi, 2000). Hence, the aim of this study is to compare the effect of oral melatonin and oral midazolam on preoperative anxiety. Emergence delirium (ED) was first described in the literature in the early 1960s. Although often used interchangeably with emergence agitation, it is defined as a temporary dissociated state of consciousness after discontinuation of anesthesia. The characteristics that make up ED include irritability, inconsolable crying, distress and inability to cooperate (Reduque and Verghese, 2013). Midazolam is the most prescribed oral premedication in the preoperative setting. Its benefits include preoperative anxiolysis, amnesia, relatively rapid onset and short duration of action. Although most children have anxiolysis with midazolam, up to 29% may display a paradoxical agitation response (Shin et al., 2013). Oral melatonin doses up to 0.4 mg/kg (maximum 20 mg) are effective in reducing ED in children (age 3-7 years) (Kain et al., 2009). AIM OF THE WORK The study aims to compare the effects of oral melatonin and oral midazolam on preoperative anxiety as a premedication in children undergoing tonsillectomy.

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.

Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.

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.

Preparing Kids for MRI Using VR

Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. This single-center, three-arm randomized clinical trial evaluates whether (1) Home+Booster VR (an age-appropriate 360° VR module at home \~24-48 hours before MRI plus a brief on-site refresher immediately before positioning), (2) Pre-Scan VR only (same module viewed on site immediately before positioning), or (3) Usual Care without VR improves MRI image quality and tolerance in children undergoing their first-ever MRI. Eligible participants are children scheduled for clinically indicated, non-emergent MRI with no prior MRI experience. Major exclusions comprise MRI contraindications; contraindications to VR use (e.g., uncontrolled epilepsy or severe motion sickness); uncorrected severe visual/hearing impairment precluding VR viewing; and inability to provide assent/consent. After consent/assent, participants are randomized 1:1:1 to one of three arms. Anticipated enrollment is \~150 total (\~50 per arm; up to 60 per arm if feasible). All arms receive routine safety procedures and child-oriented coaching per institutional practice. The VR module (\~8-10 minutes) provides a 360° walkthrough of the MRI process (sounds, positioning, keeping still) with child-focused narration. Adherence (timestamps/duration) is recorded where applicable. The primary outcome is motion artifact rated on a predefined ordinal scale by a board-certified radiologist masked to allocation; the proportion achieving diagnostic quality without repeat/sedation is also reported. Key secondary outcomes include sedation requirement, number of repeated sequences, total scan room time, scan completion without interruption, and change in child anxiety (mYPAS-SF). Additional prespecified measures include comfort/calmness Likert scales, Wong-Baker FACES pain, CEMS during scan, parent state anxiety, satisfaction VAS, physiologic vitals (heart rate, blood pressure, SpO₂) at defined peri-scan time points, observed crying and movement durations, and total scan duration. The trial uses parallel assignment with allocation concealment and masked outcome assessment. Analyses follow intention-to-treat with prespecified subgroup exploration by age bands (5-7 vs 8-10). Recruitment is planned for October 6, 2025; primary completion is expected within approximately three months.

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.

AI Toothbrush and Visual Pedagogy to Improve Oral Hygiene in Children With Autism Spectrum Disorder

This randomized clinical trial evaluates the effectiveness of an AI-enabled electric toothbrush and visual pedagogy materials in improving oral hygiene among children with autism spectrum disorder (ASD). The study compares plaque control, gingival health, and adherence between children using a manual toothbrush with visual pedagogy support and those using an AI-enabled electric toothbrush with app-based monitoring.

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.

SAFIR Family Talk - Investigating the Effect of The Family Talk Intervention

The goal of this clinical trial is to test the effect of the Family Talk Preventive Intervention compared to service as usual for families where a parent has mental illness. Participants are the parent with a mental illness receiving treatment from a secondary mental health service within the last two years from inclusion, their youngest child aged 7-17 years and the other parent of this child. The main questions it aims to answer are: Is Family Talk superior to service as usual regarding improving? * The child's level of functioning * The parent's sense of competence * Family functioning Participants will undergo interviews and fill out questionnaires. Half will be randomized to Family Talk and receive a manualized, family-based intervention of approximately 8 conversations with a trained, Family Talk interventionist. The other half will be randomized to service as usual which is normally two conversations with a professional in the mental health sector. The researchers will compare the two groups on child's level of functioning, parental sense of competence and family functioning.

Oral Tacrolimus vs Dexamethasone Micro-pulse Therapy in Pediatric Rapidly Progressing Vitiligo: A Multicenter RCT

This clinical study aims to compare the safety and effectiveness of two treatments-oral Tacrolimus capsules and Dexamethasone micro-pulse therapy-in children aged 4-12 years with rapidly progressing vitiligo. The study is a multicenter, randomized, controlled trial involving 90 participants, who will be divided equally into two groups. One group will receive daily Tacrolimus, while the other will take Dexamethasone on weekends. Over 24 weeks, doctors will monitor improvements in skin repigmentation, side effects, and overall health through regular check-ups and blood tests. The goal is to determine which treatment better controls disease progression and improves quality of life for children with vitiligo. Key Points: * For children with rapidly spreading vitiligo. * Compares two common medications. * Follows participants for 6 months. * Focuses on safety and effectiveness.

Vascular Complications in Children From T1D Diagnosis

Cardiovascular disease is a complication of type 1 diabetes (T1D), a life-long disease, usually diagnosed in childhood. The goal of this project is to determine the timing and factors leading to vascular damage in children from T1D diagnosis.

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.

A Study of Child Injury Based on Data Mining

A comprehensive pediatric injury burden assessment is an essential foundation for formulating injury prevention strategies and improving emergency care for injured children. Although the hospital-based passive surveillance of national injury surveillance system of medical and health institutions has been well-established in China, the monitoring points of hospitals were not stratified according to children's hospital. Aim of the project is to collect epidemiological and clinical data to describe causes, clinical features and outcomes of pediatric injuries at a Children's Hospital in Shanghai, China. The project intends to establish a method for collecting and analyzing high quality data of child injury using data mining based on the hospital information system.

The Effect Of Aromatherapy Applied To Children Aged 9-12 On Exam Anxiety, Attention Deficit and Academic Success

This study was planned to examine the effects of aromatherapy applied to children aged 9-12 on exam anxiety, attention deficit and academic success. The study was conducted as single blind. Hypotheses of the Study H1: Children given lemon aroma with an aromatherapy diffuser have higher Burdon Attention Test mean scores than children in the placebo group; H1.1. Burdon Attention Test mean scores are higher. H1.2. Westside Exam Anxiety mean scores are lower. H2: Children given lavender aroma with an aromatherapy diffuser have higher Burdon Attention Test mean scores than children in the placebo group; H2.1. Burdon Attention Test mean scores are higher. H2.2. Westside Exam Anxiety mean scores are lower. H3: Children given lavender aroma with an aromatherapy diffuser have lower Westside Exam Anxiety mean scores than children given lemon aroma; H3.1. Westside Exam Anxiety mean scores are lower. H3.2. Burdon Attention Test mean scores are higher.