Clinical Research Directory

Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes

The goal of this observational study is to describe data on Israeli children and youth using the 780G system including data regarding glycemic control parameters, various questionnaires, sleep data, bioimpedance measures, and dietary parameters. The main questions it aims to answer are: • whether the 780G system will improve glycemic control • whether the psychosocial aspects will improve. Participants will be followed once connected to 780G, at baseline, one, three, six months, 1 year, and two years after the connection.

Urine and Ultrasound Screening for Kidney Disease in Children

The aim of this study is to early detect kidney disease in the natural population cohort of children by urine and ultrasound screening, to assist in the precise prevention and treatment of children's kidney disease, and to establish a risk prediction system for children's kidney disease. About 10,000 children called KunQi Cohort are born in Jiangsu Province(8,000 in Kunshan and 2,000 in Qidong) and about 3,000 born in Shanghai. Through the project, child who is found with abnormal urine or ultrasound result will be referred to Children's Hospital of Fudan University to get further examination and treatment.

ECMO Treatment of Children in China in the Past 10 Years

It is a cross-sectional study to summarize the extracorporeal membrane oxygenation （ECMO）treatment in children in China.

Custom Non-invasive Ventilation Masks in Children

One significant challenge to non-invasive ventilation (NIV) use in children is finding masks to fit a wide range of growing shapes and sizes. While the technology has improved with development of masks specifically for children, the range of options remains limited. Given the smaller size relative to adults, craniofacial abnormalities and craniofacial differences are more likely to compromise mask fit for children. A poor mask fit is uncomfortable, alters delivery of airway pressure, and, in some children, leads to failure of NIV and the need for surgical insertion of an airway in the neck to deliver positive airway pressure through a tracheostomy. This makes expanding the technology to deliver NIV vital and custom NIV masks an exciting solution.In this study, this study will enroll children who are established on long-term NIV with at least some use within 3 months of starting this therapy but who have non-optimal adherence. After consenting to participate and completing demographic and health questionnaire, participants will undergo a facial scan using stereophotogrammetry. This scan will be imported into a computer-aided design software to create a NIV mask customized to the individual face. The steps of mask testing will include: i) Bench testing to compare the leak and comfort parameters of the current commercial mask used by the participant to the custom mask: ii) Efficacy of treatment as measured by polysomonography iii) NIV compliance from machine downloads; iv) Questionnaires to assess the subjective comfort, fit, and adverse events Finally, participants and their parents/guardian will be asked which mask they prefer and why.

Effects of Posture and Quality of Life in Duchenne Muscular Dystrophy Children

Duchenne muscular dystrophy (DMD) is an X-linked recessive neuromuscular disorder predominantly affecting boys and men, with an estimated incidence of 1 in 3,800 to 1 in 6,200 live male births. This condition leads to progressive muscle weakness due to the absence of the dystrophin protein, which is essential for maintaining muscle cell integrity. Symptoms and functional impairments typically become apparent by the age of two, and individuals with DMD have an average life expectancy of around 28 years. Treatment is generally multifaceted, focusing on enhancing quality of life (QOL) and postural control. The Alexander technique is employed to improve QOL and postural tone, as well as to modify body schema, with reported benefits from these changes. This method leverages spatial attention and executive functions that influence basic motor skills through targeted attention, intention, and haptic communication, thereby enhancing the QOL and postural control of the upper limbs. The aim of the study is to determine the effects of Alexander's technique on postural control of upper limb and quality of life in children with duchenne muscular dystrophy.

Effects of Traditional Game in School Going Children

This randomized controlled trial examines whether regular participation in the traditional game \*\*Kho-Kho\*\* improves agility and reaction time in school-aged children. Due to limited physical education in schools, many children fail to achieve recommended daily physical activity, leading to physical and mental health issues. The study will involve \*\*48 children (8-12 years)\*\* from selected schools in Sialkot, divided into an experimental group (Kho-Kho) and a control group (free play). The intervention will be conducted \*\*3 times per week for 6 weeks\*\*, and outcomes will be measured using the \*\*T-Test, Ruler Drop Test, and TOES\*\*. Data will be analyzed using \*\*SPSS v21\*\*, with ethical approval from \*\*Riphah International University, Lahore\*\*.

The Effects of SITS in Children With Autism.

The study will include 30 participants whose pre and post values will be calculated. Inclusion criteria for this study is autism spectrum disorder with the age group of 5\_11 years ,female and males both are included, those who are physically handi-capped and involved in some other neurological disorder or taking hypnotic and sedative drugs will be excluded. Participants will receive sensory integrated exercises (SIT) . Outcome to be measure and analyze will be repetitive behavior, communication, social interaction and motor skills. Tools used for data collection are REPETITIVE BEHAVIOUR QUESTIONNAIRE (RBQ-2). Gallium autism rating scale (GARS) second edition. Data will be analyzed through the SPSS version 23:00

L-citrulline to Improve Adverse Outcomes in Admitted Children (EChiLiBRiST, Clinical Trial 2, Inpatients)

In low and middle-income countries, children admitted to hospital are not similarly ill, and do not all have a comparable prognosis. In fact, understanding at first encounter their risk of developing adverse outcomes (including mortality) could allow a more focused management and the tailoring of specific interventions to decrease in hospital mortality, and post discharge adverse longer-term outcomes. This clinical trial, part of the EChiLiBRiST larger project ("Development and validation of a quantitative point-of-care test for the measurement of severity biomarkers to improve risk stratification of fever syndromes and enhance child survival") has the two-fold objective of: 1. Assessing whether a POINT-OF-CARE rapid triaging test (PoC RTT) based on the quantitative measurement at the bedside of the "prognostic" biomarker sTREM-1 (soluble-triggering receptor expressed on myeloid cells 1) can reliably identify those admitted children with a higher risk of adverse outcomes; and 2. Assessing whether the therapeutic intervention (the L-arginine precursor, L-Citrulline, key in the nitric oxide biosynthesis), administered orally for 28 days to those children aged 1-\<60 months identified as "moderate-to-high risk" by the prognostic biomarker can improve outcomes as compared to those receiving an indistinguishable placebo. This second objective will be assessed in a prospective multi-country, multi-site, individually randomised, two-arm, placebo-controlled, double blind clinical trial involving \~888 children 1-\<60m of age admitted to hospital and determined to be at high risk of adverse outcomes by their baseline sTREM-1 levels. The trial will compare the efficacy of a twice-daily dose of L-citrulline syrup vs placebo (200-300mg/kg/day depending on weight-band; for 28 days) in reducing adverse outcomes in children with severe disease. The trial will be running independently but in parallel in two high-mortality settings in Mozambique and in Ethiopia.

A Rapid Triage Test to Improve Risk-stratification of Febrile Children (EChiLiBRiST, Clinical Trial 1, Outpatients)

The overall aim of the study is to provide evidence that introducing novel biomarkers evaluation at triaging (first clinical assessment), in combination with IMCI-based guidelines (SoC), is a viable strategy to enhance rapid and accurate identification of febrile children at increased risk of life-threatening infections compared to IMCI-based strategies alone (SoC), and to demonstrate whether this results in enhanced decisions of admission/referral vs discharge, and enhanced overall health outcome of children with acute fever in sub-Saharan Africa.

The Effect of Animated Movies and Storybooks on Fear and Anxiety Levels in Children With Type 1 Diabetes

This study aims to evaluate the effects of animated films and story books on the fear and anxiety levels of children with newly diagnosed type 1 diabetes.

The Effect of Therapeutic Play Applied Before Intramuscular Injection

This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures. Children, especially at an early age, show great sensitivity towards medical procedures, and these processes can often cause pain, anxiety and fear. This research aims to evaluate the effectiveness of a therapeutic toy doll developed to reduce the levels of fear, anxiety and pain experienced by children aged 4-6 during intramuscular injection procedures. Children, especially at an early age, show great sensitivity to medical procedures, and these processes can often cause pain, anxiety, and fear. This research aims to discover methods of managing and improving children's responses to medical procedures through therapeutic games. This study, to be conducted at the Emergency Department of Atatürk University Research Hospital in Erzurum, will be carried out using a randomised controlled design. Participants will be randomly assigned to intervention and control groups. Children in the intervention group will prepare using the therapeutic toy doll, while children in the control group will receive an intramuscular injection at the clinic using routine application methods. Data collection tools will include the Socio-demographic Information Form, the Children's Fear Scale (CFS), the Children's Anxiety Scale-State (CAS-D), and the Wong-Baker Facial Expression Rating Scale.

Mindfulness-Based Emotion Regulation Training for Hospitalized Children

Hospitalization and medical procedures are a significant source of stress and anxiety for school-age children aged 7-11, who, due to their cognitive development, can perceive events but lack the capacity to cope effectively. The main objective of this project is to examine the effect of Mindfulness-Based Emotion Regulation Training, which will be applied to children aged 7-11 hospitalized in the pediatric clinic, on developing children's emotion regulation skills and reducing their fear levels related to the hospital. The research is a randomized controlled trial to be conducted between April 2026 and April 2027. Data will be collected using the "Child and Parent Introduction Form," the "Emotion Regulation Scale for Children and Adolescents," and the "Medical Procedure Fear Scale." While distraction techniques frequently used in the literature offer a quick and effective solution at the time of the procedure, this project differs in that it aims to provide children with sustainable emotion regulation skills that they can use not only at that moment but also in later stages of the illness and in future life events. As a result of the project, it is expected that the implemented training will increase adaptive emotion regulation strategies in children, significantly reduce medical fear and anxiety, and provide an evidence-based nursing intervention that will facilitate children's compliance with treatment.

Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years

Main objective : Evaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16 Hypothesis : Practice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer

Effects of Bulgarian Exercises on Lower Limb Function in Children

The objective of this study is to investigate the Effect of Bulgarian bag exercises on lower limb function, posture and balance among school going students. In this investigation, our study will include 379 participants girls and boys in our study. Non-Probability Convenient sampling will be used in this research. In this investigation, will collect data from Lahore primary school going girls and boys. The sample that will be included in our study will be 8 to 16 years of age, with both genders, Informed consent, Healthy children without any diagnosed physical or neurological impairments that could affect motor skills or agility. This study use following tools in our study Postural awareness scale PAS-E, Berg balance scale, The lower extremity functional scale.

Effect of Pillates on Children With Backpack Syndrome

This randomized clinical trial focuses on a sample of 139 of children diagnosed with backpack syndrome, assessing both subjective pain levels and objective measures of trunk muscle endurance before and after a structured Pilates intervention. The Pilates regimen is designed to strengthen core muscles, improve flexibility, and promote better posture, all of which are critical for mitigating the adverse effects associated with heavy backpack use.Data will be collected from North Star School Allama Iqbal town,Lahore,Standard Grammar School, Allama iqbal town ,Kips School, Allama iqbal town,Ali School System, Allama Iqbal Town Using standardized pain assessment scales(VAS) and endurance tests(Modified Biering-Sørensen Test), the effect of pilates on pain and trunk endurance will concluded and the data will analysed with spss 23

Effects of Dynamic Surface Exercise Training in Children With Diplegic Cerebral Palsy

Data will be collected after the approval of synopsis a total of 14 children with diplegic cerebral palsy of age between 6 and 8 years of both genders with Gross Motor Function Classification System of level III and IV will be recruited to participate in randomized controlled study. The study will be completed within 10 months after the approval of the synopsis. Technique of the study is non-probability convenient sampling technique. Recruited will be randomly divided into two groups, dynamic surface exercise training (DSET) group and standard physiotherapy training group. Both the groups receive active training program lasting for 60 minutes, 4 days/week for 6 weeks who have the ability to follow and accept verbal instructions. Gross Motor Function Measure (GMFM)-88 and Pediatric Balance Scale (PBS) and Time up and go test scores will be recorded at baseline, and at the end of 6-week post-intervention.

Metabolic and Hemodynamic Reserve in Pediatric SCA

The purpose of this research study is to better understand how blood flow and metabolism change can influence brain development in the early decades of life. SCA participants and healthy controls are age and sex-matched for comparison. Within the SCA cohort, children with infarcts may have thinner cortices than those without, reflecting a greater loss. The investigators will examine brain blood flow and metabolism using magnetic resonance imaging (MRI). The brain's blood vessels expand and constrict to regulate blood flow based on the brain's needs. The amount of expanding and contracting the blood vessels may vary by age. The brain's blood flow changes in small ways during everyday activities, such exercise, deep concentration, or normal brain growth. Significant illness or psychological stress may increase the brain's metabolic demand or cause other bigger changes in blood flow. If blood vessels are not able to expand to give more blood flow when metabolic demand is high, the brain may not get all of the oxygen it needs. In extreme circumstances, if the brain is unable to get enough oxygen for a long time, a stroke may occur. Sometimes small strokes occur without other noticeable changes and are only detectable on an MRI. These are sometimes called "silent strokes." In less extreme circumstances, not having a full oxygen supply may cause the brain to grow and develop more slowly than when it has a full supply. One way to test the ability of blood vessels to expand is by measuring blood flow while breathing in carbon dioxide. Carbon dioxide causes blood vessels in the brain to dilate without increasing brain metabolism. During this study participants may be asked to undergo a blood draw, MRI, cognitive assessments, and brief questionnaires. The study team will use a special mask to control the amount of carbon dioxide the participants breathe in.

Effect of Incentive Respiratory Training on Pulmonary Functions and Functional Capacity in Children With B-thalassemia Major

The study was done to: 1. Investigate the effect of respiratory training on functional lung capacity and 2. To detect the effect of respiratory training on pulmonary functions in children with β-thalassemia major. 3. To detect the level of oxygen saturation and heart rate during and after blood transfusion in children with β-thalassemia major.

Effect of Sevoflurane on Sweat Threshold in Children of Different Ages

Hypothermia is a common complication in pediatric anesthesia. Hypothermia will prolong the recovery time of anesthesia, and may also lead to increased oxygen consumption, prolonged blood coagulation time, and affect the metabolism of anesthetic drugs and postoperative immune function. Sevoflurane is the most commonly used inhaled anesthetic in children. This study explored the effect of sevoflurane on the sweat threshold of pediatric patients and analyzed the characteristics of body temperature regulation in children of different ages under anesthesia, which will help to understand the mechanism of body temperature regulation in children under anesthesia, and also provide a scientific basis for clinical anesthesia temperature management.

Artificial Intelligence in New Cardiac MR Markers for Congenital Heart Disease

The goal of this study is to investigate children with aortic and pulmonary valve disease treated or untreated longitudinally. Established CMR measures with additional newly developped, promising, highly refined and clinically applicable quantitative imaging biomarkers, will be utilized as compared to the conventional CMR estimates. The main question\[s\] it aims to answer are: * \[question 1\]To evaluate risk stratification for surgery and intervention of the aortic- and pulmonary valve * \[question 2\]Investigate the cardiac and vascular hemodynamic and morphological changes before and after interventional or surgical treatment of the aortic- and pulmonary valve at short and long term. Participants will undergo cardiac MRI before and after interventional or surgical treatment of the aortic or pulmonary valve Researchers will compare MRI data to an age matched control group established at the department in another study.

Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis

The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.

The Effect of the Educational Movie Shown to Pediatric Patients Receiving Intrathecal Chemotherapy Treatment on Pre-Procedure Fear and Post-Procedure Pain in Children

In this study, which is planned to be conducted in a randomized controlled experimental design, nonpharmacological methods (educational film shown with virtual reality goggles and cartoon shown with virtual reality goggles) applied to children aged 5-10 years who will receive intrathecal chemotherapy treatment before intrathecal chemotherapy treatment were evaluated. It is aimed to determine the effect on pre-procedure fear and post-procedure pain. The study is planned to be conducted between November 2024 and November 2025. The population of the study will consist of children between the ages of 5-10 years who receive inpatient treatment in the Pediatric Hematology Clinic of Izmir Ege University Hospital (Health Practice and Research Center). Random sampling method and stratified randomization method will be used for sample selection. In the calculation of the sample size of the study, using G-Power 3.1.9.7 program; type 1 error (α) 0.05, power (1- β) 99% and Cohen's effect size (δ) 0.5, the sample size to represent the main mass was determined as 90 children for this study. However, when the dropout rate is set as 10% for data loss that may occur in the study, the minimum number to be reached for the study is targeted as 99 (intervention group 1 n=33, intervention group 2 n=33, control group n=33). Research data will be collected after project acceptance. In all three groups, children and their parents will be informed before the study and their written and verbal consent will be obtained. Data will be collected by using the "Introductory Information Form", "Intervention Follow-up Form" and "Child Fear Scale (CFS)", "Wong Baker FACES (WB-FACES) Pain Rating Scale" and "Visual Analog Scale (VAS)" prepared by the researchers with the feedback of nurses, parents and children. Statistical analyses will be performed using IBM SPSS Statistics 26.0 (IBM SPSS Statistics for Windows) package program. The significance level will be set as 0.05 in all analyzes. In the study, numerical data will be calculated using mean, standard deviation, median, minimum, maximum values and categorical data will be calculated using frequency and ratio values. With the nonparametric Brunner-Langer model, the before-after change (group effect, before-after effect and interaction effect) of fear scores in the educational film, cartoon and control groups will be examined using R 3.3.1 software (R software, version 3.3.1, package: nparLD, R Foundation for Statistical Computing, Vienna, Austria; http://r-project.org). In order to visually examine this change, the 'relative effects' graph (since the nonparametric method is used) will be utilized. When the Brunner-Langer model shows that the before-after change in the groups is not similar (interaction \< 0.05), the before-after comparison in each group will be made separately with the Wilcoxon sign test, and the differences between the groups will be compared with the Kruskal-Wallis test by taking the after-before difference. After Kruskal-Wallis, pairwise comparisons will be made with the Dunn test, and then Bonferroni correction will be used for p values. The agreement between the measurements of Nurses, Parents and Children will be evaluated by Intraclass Correlation (ICC) analysis.

Emergency Care Action Plans for Infants with Medical Complexity

An Emergency Care Action Plan (ECAP) is a tool intended to be helpful to providers when treating a child with complex medical needs during an emergency. Once created, ECAPs are added to the Electronic Health Record (EHR), shared with the child's caregiver(s), and kept up by all of those involved in a child's care. The goal of this study is to measure important health outcomes (ex. inpatient days, emergency department visits) in terms of the use of the ECAP for infants discharged from the Neonatal Intensive Care Unit (NICU). This study will also measure other real-time potential challenges related to the use of the ECAP including, but not limited to, if it is being used, if providers and caregivers want to use it, and if they keep using it over a long period of time.

Pharmacokinetic Infliximab Data in Pediatric Crohn's Disease

Rationale: Crohn's disease (CD) is a chronic, debilitating inflammatory bowel disease (IBD) which is diagnosed during childhood in up to one in ten patients. The use of anti-tumor necrosis factor (TNF)-α agents has significantly ameliorated CD management. Infliximab (IFX) is the first anti-TNF-α agent registered for pediatric CD. The current dosing recommendation of IFX is extrapolated from adult studies, and it is a weight-based dose (5 mg/kg) delivered during induction (infusion at weeks 0, 2, and 6) and maintenance (every 8 weeks). However, pediatric patients have a 25-40% lower drug exposure compared to adults, particularly children under 10 years of age, resulting in diminished efficacy and an increased risk of developing a complicated disease course. The investigators hypothesize that an intensified IFX induction scheme (instead of the current dosing recommendation) is more effective in the treatment of pediatric CD patients. Objective: The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure without treatment escalation in pediatric CD patients. Secondary objectives are clinical and biochemical remission without treatment escalation, development of antibodies to IFX (ATI) and adverse reactions. Study design: An international, multicenter, prospective, open-label trial. Study population: Anti-TNF-α naïve children (age 1-15 years) with CD and an indication to start IFX treatment. Intervention: IFX will be given intravenously at 10 mg/kg at week 0, and 5 mg/kg at weeks 2, 4, and 8 to all patients (induction). Maintenance will start at week 12, and then ideally continue every 6 weeks till week 24 (end of study). IFX trough levels will be measured at weeks 4, 12, and 24. During the maintenance, the IFX dose and/or interval adjustments, the IFX discontinuation or the start of a co-medication (i.e., an immunomodulator) will be possible on indication (i.e., primary nonresponse, secondary loss of response, intolerance to study medication) at the physicians' discretion. Follow-up will continue for the duration of the study (week 24). Main endpoint: Proportion of patients with IFX TL ≥ 5 µg/mL at week 12 without treatment escalation.