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37 active trials for Children

Cerebral Palsy and the Study of Brain Activity During Motor Tasks

Background: - Two ways to study the brain while people are moving are near-infrared spectroscopy (NIRS) and electroencephalography (EEG). NIRS uses light to look at blood flow in the brain when it is active. EEG records electrical activity in the brain. Both have been used safely for many years, even in very young children. NIRS or EEG can be used while a person is moving to show which parts of the brain are the most active. Researchers want to use NIRS and EEG to study brain activity during movement in people with cerebral palsy and healthy volunteers. Learning more about how people with and without cerebral palsy use their brain to control their muscles may lead to new ways of training people with cerebral palsy to move better. Objectives: - To study how the brain controls body movement in people with and without cerebral palsy. Eligibility: Individuals at least 5 years of age who have cerebral palsy. Healthy volunteers at least 5 years of age. Design: This study has three parts. People with cerebral palsy will be selected for all three. Healthy volunteers will be asked to do only two of them. Everyone who participates will have NIRS and/or EEG exams during movement. People with cerebral palsy may also have biofeedback sessions to train coordination of movement and brain activity. Participants will be screened with a physical exam and medical history. Urine samples may be collected. All participants will have at least one session of NIRS and/or EEG imaging studies. Sessions may also include the following tests: Magnetic resonance imaging to look at the brain Electromyography to measure electrical activity of the muscles Motion analysis of specific body parts Ultrasound to measure activity of the muscles Motorized, robotic, and electrical stimulation of the muscles Other clinical tests of muscle movement as needed. Participants with cerebral palsy will have biofeedback sessions. These sessions will help them learn to coordinate muscle movement and brain activity.

Start: August 2013

A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD)

Diagnostic pathways for children with possible autism. Which work best, for whom, when, and at what cost? Autism is a complex neuro-behaviour condition. People with autism have difficulty with social interaction and in communication with others. They may struggle with change, and repeat actions over and over. Life may be very anxious or stressful. The signs of autism can occur at any age but often appear in the first two years of life. There is no one type of autism, but many, so the condition is now called autism spectrum disorder (ASD). Autism is lifelong but this study is only about children. Caring for a child with autism can be difficult and can sometimes be tough on the whole family. This project aims to guide the people who plan services for families and children. Different teams and services that do autism assessments will help us. The investigators will ask teams and services: What speeds up diagnosis? What delays diagnosis? The study will be in four work packages: The investigators will review research in the UK and abroad to find evidence and ideas that will help speed up diagnosis. The investigators will survey professionals who work for the specialist teams who diagnose autism. The survey will be about each step in the process and ask which professionals get involved. The investigators will ask about the number of children they see and the time it usually takes to reach a diagnosis. This will give us a picture of the national situation. After the national survey, the investigators will select around six or eight teams. These teams will be using different and innovative approaches. The investigators will study those approaches. The investigators will talk to clinical staff, managers, referrers, parents and young people. Parents and young people will have gone through the diagnostic process. The investigators will ask parents and young people about their experiences and views. The investigators will review the steps in the diagnosis process for about 70 children in each service. The investigators will find out how long each assessment takes, how much clinical time it takes, and how much it costs. The investigators will compare findings across teams and services. The investigators will have national meetings with autism experts and patient groups. The investigators will show them our findings. These groups will agree recommendations for practice. Clinical teams, service managers, commissioners, parents' groups, and NHS England will receive recommendations. The research team has specialist expertise in autism, health services, economics, and statistics. The team includes public and NHS England partners. This will ensure the investigators take account of the needs of families and the investigators send the findings to people who plan services.

Start: November 2019

Stress-free Everyday LiFe for Children and Adolescents REsearch

The primary aim is to evaluate the effectiveness of a profound school teacher training programme to teach a mindfulness-based programme (.b) in Danish schools on the pupils self-reported mental well-being at seven months. The secondary aims are to evaluate i) the effectiveness of the profound school teacher training programme to teach the .b-programme in Danish schools on the pupils self-reported mental well-being post intervention (at five months).

Start: August 2020

Effects of Systematic Proprioceptive-tactile Stimulation With Use of the Protac MyFit®

Children with sensory impairment (SPD) are often unable to sit still and focus their attention. This can affect the children by limiting their opportunities for participation in school activities. Previous studies indicate a link between childhood SPD, childhood anxiety, and obsessive-compulsive disorder (OCD) in adulthood. Research and clinical experience suggest that systematic use of proprioceptive-tactile stimulant aids may have a positive effect for children with SPD. The aim of the project is to investigate and describe the effects of a systematic use of proprioceptive-tactile stimulating vest, MyFit®, for children 6-12 years with SPD in the form of sensory-seeking behaviour. Research questions: Can systematic use of MyFit® for children with sensory seeking behaviour increase their participation in school activities? Can systematic use of MyFit® support children with sensory seeking behaviour to increase their awareness, concentration and focus on tasks? Can systematic use of MyFit® affect children's feelings of confidence and self-efficacy? The project seeks to answer these questions to contribute to knowledge on how children with sensory seeking behaviours can be supported for better participation in school activities. The study will be a randomized controlled trial of 240 children with SPD and sensory seeking behaviour.

Start: April 2020

Long-term Exercise Effects From Robotic Walking

The vision of the Long-term Exercise Effects from Robotic Walking (LEER) research program is to develop optimal, individualized exercise strategies that would in turn enhance the health and well-being of non-ambulatory children with cerebral palsy (CP). To date, it has not been possible to study exercise among non-ambulatory children with cerebral palsy in a structured and standardized manner. Improved possibilities to carry out such studies are now offered by the robotic medical device Innowalk, which allows various training options in an upright weight-bearing position. In order to design optimal exercise strategies for children with cerebral palsy, the investigators will examine the effects of two tailored training programs, using Innowalk. Changes in cardiopulmonary and metabolic parameters, and in the levels of brain derived neurotropic factor (BDNF), nerve growth factor (NGF) and vascular endothelial growth factor (VEGF) will be examined. The investigators will assess the acute (1 day), adaptive (16 weeks), and long-term (1 year) effects of the exercise programs through indirect calorimetry and blood samples at multiple time points. The investigators will also study the environmental and behavioral factors facilitating and hindering participation in exercise, by semi-structured interviews. The goal is to design improved individualized exercise programs that will increase health and well-being in the children and their families, thereby decreasing the use of medications and healthcare.

Start: May 2019

The Impact of Activity Breaks on Cognitive Function, Adiposity and Fitness in Preschoolers

Project which objective is a) to test the effectiveness, in preschool children, of an integrated physical activity intervention in the classroom based on intervallic training (MOVI-HIIT) on improving executive function, body composition, cardiorespiratory fitness and b) to evaluate teachers' perceptions of barriers and facilitating elements for the implementation and monitoring of MOVI-HIIT interventions in the classroom.

Start: June 2020

The Rate of Full and Empty Stomach in Elective and Emergency Pediatric Patients

Background and Aim: Pulmonary aspiration of gastric content in the perioperative period is rare, but it is an important cause of morbidity and mortality that anesthetists never want to encounter. Due to reasons such as emergency surgical procedures, communication problems with pediatric patients or their parents, impaired cognitive function, obesity, diabetes mellitus, chronic liver and kidney diseases, it is observed that there is sometimes inconsistency between the periods defined in the preoperative fasting guidelines in pediatric patients and the state of gastric content and volume encountered in clinical practice. There is a lack of data on children on this issue. In this study, primary we aimed to evaluate the incidence of empty and full stomach in pediatric patients who underwent elective and emergency surgery in our routine anesthesia practice. Also we want to determine the relationship between fasting time and qualitative assessment of gastric content. Secondary this study sought to examine whether correlation between gastric ultrasound finding and fasting time, and also to determine relationship with the current comorbidities. Design: This is a prospective, single blinded, observational study. The minimum sample size required to determine the prevalence of full stomach, 0.05, within the limits of ± 0.025 with 0.95 confidence, was calculated as 292. When calculating with the proposed equation of n = 100 + 50i to determine the factors affecting by logistic regression (here i is the number of variables in the model), the minimum number of samples required for logistic regression analysis was calculated as 300 in case of 4 independent variables in the model. n=100+50*4= 300 Methods: Pediatric patients younger than 18 yr old who are to undergo elective and emergency surgery under general anaesthesia at our hospital are enrolled in this prospective observational study between April and December 2021. Preoperative ultrasound examination of the gastric antrum are performed by one anesthesiologist who has been instructed and supervised by an experienced pediatric radiologist and who is blind to the patient's history. Ultrasonographic measurement of the gastric antral cross-sectional area (CSA) are performed in supine position and right lateral decubitus position (RLD). The gastric antrum is imaged in a sagittal plane, between the left lobe of the liver and the pancreas, at the level of the aorta, as previously described [1]. This examination allowed qualitative assessment of gastric contents according to the three-point grading scale previously described by Perlas and colleagues[2]. Grade 0 was defined by the absence of appearance of any content in a flat antrum in both the supine and the RLD positions. Grade 1 was defined by the appearance of any gastric content in the RLD position only, and Grade 2 was defined by the appearance of any content in both the RLD and the supine positions. The antral cross-sectional area is also calculated in both position, by measuring the longitudinal diameter (D1) and the anteroposterior diameter (D2) of the antrum, from serosa to serosa using this formula [3] Antral area= (? x D1 X D2) / 4. Patients' characteristic data ( age, gender, weight, height, BMI and ASA physical status classification), fasting duration, type of elective and emergency surgery, chronic disease and complications (regurgitation, pulmonary aspiration, etc.) that may develop during the peroperative period are recorded.

Start: April 2021

The Relationship Between Oxygen Reserve Index and PaO2

Oxygen Reserve Index (ORI) is a new parameter for noninvasive monitoring of oxygen reserve using oximetry sensor. In this study, the investigators evaluate the correlation between ORI and the partial pressure of arterial blood oxygen (PaO2) in children.

Start: February 2020

Health in Childhood Following Assisted Reproductive Technology

The purpose of this trial is to investigate the metabolic and cardiovascular health in children aged 6-8 years born after in-vitro fertilization with frozen embryo transfer

Start: January 2019

Vaccine Campaign Effects on General Hospital Admissions and Mortality Among Children

The world is set on eradicating measles and polio infections in the coming decade. Once both infections are under control, campaigns with measles and oral polio vaccines will be phased out. This might do more harm than good for child survival in low-income countries. Studies from the Bandim Health Project in Guinea-Bissau, and elsewhere, have revealed, that the live measles and oral polio vaccines have beneficial non-specific effects, i.e. effects on child morbidity and mortality unrelated to prevention of the targeted diseases. The campaigns are presumed to be most beneficial for children not reached by routine vaccination programs, as they are not already protected. However, studies show that prior routine or campaign vaccination may boost resistance against unrelated infections. If we phase out measles and oral polio campaigns after eradicating their target infections without considering the impact on child survival, the drastic decline in child mortality since 1990 could change direction. We will conduct the first cluster randomized controlled trial to evaluate the effect of measles and oral polio campaigns on general child morbidity and mortality via the Bandim Health Project. Bandim Health Project runs a Health and Demographic Surveillance System in Guinea-Bissau since 1978 and assesses child health interventions' real-life effects, via continuous registration of all interventions given to all children, and follow-up of individuals. We will conduct the trials in rural Guinea-Bissau monitoring all nine health regions. The hypotheses are: RECAMP-MV: Measles vaccination campaign in Guinea-Bissau reduce morbidity and mortality among children between 9 and 59 months of age by 80% during the subsequent 18 months in a context of limited measles infection. RECAMP-OPV: Oral polio vaccination campaigns in Guinea-Bissau reduce morbidity and mortality among children between 0 and 8 months of age by 25% during the subsequent 12 months in a context with no polio infection. Originally, the trials were meant to be implemented in 182 clusters, enrolling 21000 children. Following revised sample size calculations and discussions with the Data Safety and Monitoring Board, the number of clusters were increased to 222 and the planned number of enrolments increased from 21,000 to 28,000 (RECAMP-MV: 18000, RECAMP-OPV: 10000). To explore the hypothesis that at least part of the beneficial non-specific effects of OPV is driven by changes in the gut and/or respiratory microbiome, we will collect microbiome samples in a sub-group: A nasal swab and a rectal swab will be collected from 50 infants allocated to the intervention group, and 50 infants allocated to the control group. Two sample will be collected for each infant one when recruited for RECAMP-OPV and a second two months later.

Start: November 2016

Community Outreach - Obesity Prevention Trial (CO-OPT)

The purpose of this research is to investigate the effectiveness of a community health worker-based program as an adjunct to clinical services regarding childhood obesity management. This family-centered program will be delivered in the community and homes of enrolled families. The primary outcome will compare change in age-gender specific body-mass-index (BMI) z-score (zBMI) over time. All Denver Health children and families will be enrolled at study inception and receive the intervention in 1 of 5 defined 6-month stepped wedge engagements. The intervention lasts for 6 months and the time prior to engagement in the intervention will serve as the control period. Intervention construct validity will be evaluated using data on diet, activity, and fitness. The primary goal is to examine the effect of the intervention in reducing the zBMI in the index patient and secondarily on any participating family members. We will test effectiveness among demographic groups under-represented in prior studies, including very young children and Latinos. Results from this study will inform future intervention modifications and permit effect size estimation and power calculations for future randomized trials that include a community health worker-based obesity prevention and treatment program. During the course of the study, an obesity registry will be designed and implemented within an integrated safety-net healthcare system to measure primary obesity outcomes in a low-income population and conduct analyses. The community health worker will be using several new technologies (e.g., text messaging and patient relationship manager [PRM]) as an adjunct when working with an obese child and his/her family. Targeted training for clients, providers and CHW will be part of the prevention strategies implemented during the grant period, these will include motivational interviewing. All of these (i.e., obesity registry, technologies and training) will have an evaluative component.

Start: March 2012

Effects of Gestational Diabetes Mellitus on Children

Abstract Gestational diabetes mellitus (GDM) refers to different degrees of glucose intolerance or impaired glucose tolerance,which are commonly found on non-diabetic persons during pregnancy.GDM is an important public health issue that has a huge impact on children's health.According to statistics,the global occurrence of GDM in 2017 was as high as 16.2%.As well as lifestyle changes that are leading to an increased number of women with overweightness and obesity,the increasing number of"older mothers"responding to the second-child policy are raising up the percentile of GDM by the year.infancy and pre-school age are the important stages of physical growth and psychomotor development.At present,there are few domestic and International studies on the impact of GDM on the health of children,and the conclusions are not the same.There is a lack of long-term follow-up and Chinese samples. This study focuses on the current new hotspot in the research of the children's health problems, based on the 1000-day life concept and theory of DOHaD. Prospective cohort study methods and real-world studies were used. To study and clarify the effect of GDM on the neuropsychological development and physical growth indicators of children in China, and further explore the possible mechanism of action and the related indicators of predictive value, looking for possible early intervention targets. The results are expected to expand the data sources of this type of research in China, improve the data quality and clarify the characteristics of this type of population in China, and provide data support for the revision of maternal and child health related policies.

Start: June 2019

Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses

The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC). The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention/survival of the zirconia RBFDPs pretreated with APA and NAC.

Start: January 2018

Differentiate Children Septic and Inflammatory Arthritis by Comparative Analysis

The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .

Start: February 2019

New Tools for Predicting Capillary Leak Shock During Dengue Fever

Evaluate the prognostic value of different methods (Osmometry / clinical-biological score) compared to the occurrence of capillary leak shock during dengue fever.

Start: May 2020

Emla-Cream as Pain Relief During Pneumococcal Vaccination

The aim of this intervention study is to compare the efficacy of Emla cream as a pain relief or no pain relief in connection to the first pneumococcal vaccination at the age of three months in Child health care. Primary objective 1.Leads Emla cream as pain relief to children in connection with pneumococcal vaccination at the age of three months to lower pain scores in the use of FLACC as a pain measurement instrument?

Start: May 2013

The Odense Overweight Intervention Study

Strong and consistent evidence have shown that overweight, including obesity, is an important risk factor for the development of cardiovascular disease (CVD) in adults. Several studies have found an association between overweight in childhood and increased risk of morbidity and mortality later in life. The prevalence of overweight in children and adolescents has increased in recent years, and consequently it is important to identify effective approaches in the prevention and treatment of overweight in young individuals. Approaches such as resident weight loss camps have shown promising results. A residential camp setting provides an opportunity to increase and control exposure to, for instance, particular foodstuffs, beverages and physical activity opportunities. However, well-designed studies with sufficient participants are still needed on the reversal of overweight in childhood with increased focus on documenting predictors of behavior changes associated with decreases in overweight. This study is carried through as a randomized controlled trial which investigates the effect of participating in a 6 week health promoting resident for overweight fifth grade children camp followed by 46 weeks of family support. The study hypothesis is that participating in a 6 week resident camp and a following period of 46 weeks of child and family support will induce a reduction in body mass index (BMI). In addition it is expected that the intensity and duration intervention program is sufficient to cause changes in physiological parameters related to a reduced risk of lifestyle diseases.

Start: April 2012

Nutritional Status in Children Treated With Advanced Nutrition Therapy

Background: There are few studies about nutrition to children and adolescents with cancer, and in particular during stem cell transplantation (SCT). Studies from other countries suggest that malnutrition is common on admission; the situation decline during treatment and may persist for a long time. Aim: This project aims to improve the nutritional therapy to children being treated for cancer and children undergoing stem cell transplantation

Start: February 2017

Pediatric Perioperative Satisfaction Questionnaire

The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

Start: September 2020

Asthma Action at Erie Trial

The Asthma Action at Erie Trial compares the current best practice in asthma self-management education (certified asthma educator services) to an integrated community health worker (CHW) home intervention in which the real-life challenges of patients and the health care system are taken fully into account. This trial will provide clarity as to the expected effect size, cost savings, and resources needed to integrate asthma CHWs into clinical practice.

Start: April 2015