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NCT ID: NCT02485314 Completed - Child Clinical Trials

Reliability and Validity of Turkish Version of PEM-CY

Start date: March 2016
Phase:
Study type: Observational

The Participation and Environment Measure for Children and Youth (PEM-CY) is the first instrument that combines parental assessment of children's participation in home, school, and community activities with qualities of each environment that are perceived to support or hinder participation. This combined format may help to clarify the relative impact of environmental factors (including the natural and built environment), compared to personal factors, on children's participation in specific settings. The aim of this study was to examine reliability and validity of Turkish version of the Participation and Environment Measure for Children and Youth (PEM-CY).

NCT ID: NCT02471521 Completed - Anesthesia Clinical Trials

Optimal Inspiratory Pressure for Facemask Pressure-controlled Ventilation in Children

Start date: February 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to find an optimal inspiratory pressure to provide adequate tidal volume and prevent gastric insufflation in pediatric patients. The children under 5 years old are randomly assigned to muscle relaxation group and non-relaxation group. For muscle relaxation group, routine anesthesia induction is performed with muscle relaxant and mask ventilation is started by pressure-controlled mechanical ventilation. Gastric auscultation and abdominal ultrasonography are performed simultaneously during mask ventilation to detect inflow of air. Initial inspiratory airway pressure is 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas. For non-relaxation group, mask ventilation is performed in a same manner, without muscle relaxant. After detection of gas by any of the two methods, rocuronium 0.6 mg/kg is administered and tracheal intubation is performed.

NCT ID: NCT02464865 Completed - Obesity Clinical Trials

Thiamin Deficiency in Obese Thai Children

Start date: August 2015
Phase: Phase 4
Study type: Interventional

This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

NCT ID: NCT02463149 Completed - Child Clinical Trials

Pilot Evaluation of Youth Chef Academy

YCA
Start date: August 2011
Phase: N/A
Study type: Interventional

This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based experiential culinary and nutrition literacy curriculum for middle-school students. The primary study hypothesis was that students assigned to YCA would demonstrate greater improvement in F/V and whole grain consumption compared to students in the control group. Eight classrooms in eight public K-8 schools participated in the project. Classrooms were assigned to intervention or control condition in a non-randomized manner. YCA was delivered by project staff to all of the students in the four intervention classrooms. Students completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum cohort).

NCT ID: NCT02395276 Not yet recruiting - Child Clinical Trials

Hypothermia Therapy in Pediatric Cardiac Intensive Care Unit for Suspected for Brain Injury

Coolheart
Start date: April 2015
Phase: N/A
Study type: Interventional

Cardiac pathology is a major risk for brain injury and neurodevelopmental deficit. The most common cause of cardiac pathology is congenital heart defects (CHD) about 4-8/1000 live births a year. The most common etiology of the brain insult is hypoxic ischemic injury (HII) as result of hemodynamic instability in the perioperative period. Similar insults in adults with cardiac arrest or infants with neonatal asphyxia, was successfully treated with hypothermia, initiated within 6 hours after the event. Although, hypothermia is most likely an effective treatment for HII in children with cardiac anomaly, it also carries a risk for bleeding or infection of the surgical wound. In this randomized control trial, hypothermia treatment will be compared to normothermia treatment of patients in the pediatric cardiac intensive care unit (PCICU) following severe HII in the PCICU or operating room. The effect will be quantified by MRI, serum biomarkers of brain injury, amplitude integrated EEG, neurological evaluation coagulation and infection evaluation in the acute phase and by developmental assessment at 1, 6 months and 2, 5 years. Favorable effect of hypothermia with minimal risks may open the door for the implementation of hypothermia as a standard care in PCICUs.

NCT ID: NCT02378311 Completed - Trauma Clinical Trials

Handlebar Grip Related Injury Prevention (GRIP) Study: Are Exposed Metal Handlebar Ends a Risk Factor for Injury?

GRIP
Start date: March 2015
Phase: N/A
Study type: Observational

Cycling injuries are the 3rd most common mechanism of injury in 7-13 year olds[1]. Bicycle injuries have remained one of the commonest causes of paediatric abdominal trauma for over 60 years[2,3]. 15% of child cyclist injuries involve impact with a handlebar; two-thirds of those are abdominal injuries[4]. Handlebar impact is now the commonest mechanism of major paediatric abdominal injury[3]. Serious handlebar injuries often occur after apparently minor falls; they are not unique to riders performing stunts[5]. One small study found that the metal handlebar ends were often exposed on bikes of children sustaining severe abdominal injuries[6]. Most European safety standards do not test grip durability[7-10]. Day-to-day use can damage rubber grips, exposing the underlying metal handlebar tube. This feasibility study aims to test the research methods that will be used in a subsequent nationwide multicentre study. The main study will investigate the association between injuries and handlebar grip condition. Children attending study hospitals with any bicycle or kick scooter injury will be invited to participate. Parents of injured children will be invited to complete questionnaires regarding circumstances surrounding the injury and condition of the handlebar ends on the bike or scooter involved. Clinical information regarding the injury will also be collected. The handlebar end condition will be compared between children sustaining a handlebar end injury [Cases] and riders whose injury did not involve the handlebar [Controls]. If exposed handlebar ends are more prevalent amongst riders with handlebar end injuries, injury prevention strategies can focus on methods to prevent damage occurring to grips through day-to-day use. If no such association is found, prevention strategies can be focused elsewhere, such as on design of effective protective clothing. Data collection for this feasibility study will occur between March 2015 and September 2015. The Chief Investigator, Mr. Andrew Neilson, funds the feasibility study.

NCT ID: NCT02348073 Completed - Epilepsy Clinical Trials

Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy

AGPIn3
Start date: March 2015
Phase: Phase 3
Study type: Interventional

Our project aims to develop a new therapeutic approach in epilepsy-associated attention disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids, containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children with epilepsy. Secondary objectives include: - To evaluate the impact of a supplementation of PS-Omega 3 on quality of life. - To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid profiles. - To assess the tolerance of a supplementation of PS-Omega 3. - To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures. - To describe the impact of a supplementation of PS-Omega 3, at 24 weeks, 1. on attention disorders in children with epilepsy, 2. on quality of life, 3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects aged 6- 16 years, suffering from epilepsy (any type) and attention deficit hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V criteria in 12 clinical sites in France.

NCT ID: NCT02346006 Completed - Myopia Clinical Trials

CHAMPS Eye Study - Myopia and Retinal Vascular Geometry in Relation to Physical Activity

Start date: February 1, 2015
Phase: N/A
Study type: Interventional

An increasingly physical inactive lifestyle in the Western World has led to a higher number of lifestyle -related diseases. The consequences are now already present in childhood with an increased prevalence of overweight, obesity, and diabetes. Inactivity is also accompanied by cardiovascular iseases and is also thought to be associated with an increased incidence of nearsightedness (myopia). Myopia is the most frequent eye disease globally, and causes severe personal and societal expenses and may additionally lead to secondary eye disorders such as retinal detachment, glaucoma, and cataract. The retina is the only place in the human body where it is possible to directly inspect the blood vessels (microvasculature). Photography of the eye background allows a noninvasive examination of the retinal structure in which it is possible to make measurements on the retinal blood vessels. It is well known that early vascular chances can be detected with this method and that there are correlation between these changes and systemic diseases, such as hypertension, stroke and other cardiovascular diseases. This study is a new subproject in The Childhood Health, Activity, and Motor Performance School (CHAMPS) Study Denmark, also known as the Svendborg Project. The project has a well-defined cohort with originally 1515 school students who since 2007 have been divided into two groups: schools with extra exercise during school hours and matched traditional schools. CHAMPS-DK aims to investigate the effect of increased physical activity on current and future health of children and adolescents. Thanks to this unique child cohort it is possible to investigate the correlation between physical activity, myopia and retinal vascular diameters in a large group of Danish schoolchildren. We want to study the degree and reversibility of physical activity and its effect on the development of myopia and retinal blood vessel changes. However, there is still a lack of knowledge about the correlation between physical activity and retinal vascular diameters in children. Furthermore, it is still unclear whether physical activity can prevent the development of myopia; such a realization could have far-reaching consequences in form of a modified approach to the necessity for exercise and, furthermore, potentially a significant socio-economic benefit.

NCT ID: NCT02339350 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children

Start date: January 2015
Phase: Phase 2
Study type: Interventional

Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%, thus recent studies focus on treatment intensification according to the risk group. According to the previous reports, we designed a multicenter prospective trial for pediatric ALL.

NCT ID: NCT02338440 Active, not recruiting - Child Clinical Trials

Pharmacokinetic Study of Lipo-PGE1 for Prevention of VOD After HSCT

Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Veno-occlusive disease (VOD) after hematopoietic stem cell transplantation (HSCT) remains the major complication. VOD occurs in 11-31% of pediatric HSCT and the mortality reaches up to 50%. Prostaglandin E1 (PGE1) have been reported to prevent and relieve the severity of VOD by Gluckman et al.. Lipo-PGE1 is a transporter of PGE1, which is superior in concentrating PGE1 and acts for prolonged time. Because of the prolonged effective time, lipo-PGE1 acts comparable effects by 1/4~1/8 of PGE1 dose. Empirically, pediatric HSCT centers adopt lipo-PGE1 in dose of 1 mcg/kg/day (0.042 mcg/kg/hr), which is 1/7 of the dose recommended by Gluckman, et al. This prospective study will investigate the concentration of lipo-PGE1 with preventive lipo-PGE1 with empirical dose (1 mcg/kg/day).