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Heart Defects, Congenital clinical trials

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NCT ID: NCT03558269 Not yet recruiting - Clinical trials for Congenital Heart Disease

Autologous Umbilical Cord Blood Treatment of Neonate With CHD

Start date: June 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of the study is to evaluate the feasibility and safety and efficacy of collecting and infusing autologous umbilical cord blood (UCB) in newborn infants with hypoplastic left heart syndrome (HLHS) and transposition of great arteries (TGA). Rationale: Neonates with HLHS and TGA have significant brain injury as demonstrated by peri-surgical MRI. Moreover, there a substantial tendency to suffer from chronic cardiac condition as low cardiac output state and valvular insufficiency. Treatment of neonates after hypoxic ischemic injury at birth with autologous UCB was shown to safe and improved developmental outcome. The effect of UCB is most likely achieved by reduction of free radicals injury and pro-inflammatory and apoptotic process. Hypothesis: Treatment with UCB immediately after the first cardiac surgey, with in the first week life will reduce the brain injury demonstrated by MRI and reduce the choronic cardiac problems

NCT ID: NCT03542968 Recruiting - Clinical trials for Congenital Heart Disease

Imaging by 4 DFlow in Patients With Tetralogy of Fallot

4DFlowFallot
Start date: October 12, 2017
Phase: N/A
Study type: Interventional

Conventionnal cadiac magnetic resonance (CMR) is the reference to assess changes in right heart flow and pulmonary artery hemodynamics in patients with repaired Tetralogy of Fallot. 4D Flow CMR Imaging is a new imaging modality able to assess all of these parameters faster (8 min vs 30 min) and more comfortably. The aim of this study is to compare conventionnal CMR and 4D Flow CMR for the assessment of these parameters (ventricular volume, ventricular systolic function, and regurgitation of the pulmonary pathway).

NCT ID: NCT03512613 Recruiting - Clinical trials for Congenital Heart Defect

A Pilot Study- Monitoring Cerebral Blood Flow in Neonates With Congenital Heart Defects

Start date: May 29, 2018
Phase:
Study type: Observational

Congenital heart defects have an incidence of 9/1000 live births. Infants with congenital heart defects such as Transposition of Great Arteries / Hypoplastic Left Heart are at risk for brain injury because of concomitant brain malformations. Previous studies of cerebral MRI in infants with congenital heart defects showed that in 20-40% of cases there was preoperative brain injury and post operative with the same incidence. These findings are strongly associated with early and long-term neurodevelopmental injury. There is a necessity for a non invasive device who will monitor the cerebral blood flow during the hospitalization prior and post the cardiac defect repair surgery. The previous modal of the study device has been cleared for marketing by the FDA (k150268). The main goal of this study is to demonstrate that the new design of Ornim's c-FLOW 3310-P is easy to operate and effective in monitoring changes in cerebral blood flow in neonates as demonstrated in adults.

NCT ID: NCT03502239 Not yet recruiting - ADHD Clinical Trials

Cognitive Rehabilitation (Mega Team) and Its Effects on Emotional and Behavioral Regulation in ADHD, ASD, and CHD

Start date: April 2018
Phase: N/A
Study type: Interventional

Children with disorders that impact neurodevelopment often have difficulties with executive functions and regulating emotions. Cognitive-based video game training has been shown to improve outcomes, however, this training has been expensive, has required professional supervision, and has been investigated only within a narrow group of children. The Mega Team study will test the effects of a highly engaging, take-home video game-based intervention designed to improve executive functioning in children with various brain-based developmental disorders.

NCT ID: NCT03496363 Not yet recruiting - Hypothyroidism Clinical Trials

Hypothyroidism With Congenital Heart Disease (CHD)

Start date: May 1, 2018
Phase:
Study type: Observational

Congenital hypothyroidism is one of the most preventable causes of neurocognitive impairment because early treatment is possible in neonates. The thyroid hormone is important for normal growth and development in infancy. After introducing national screening test using capillary thyroid stimulating hormone level, the incidence of untreated congenital hypothyroidism has significantly decreased. According to the Italian Registry of Congenital Hypothyroidism, congenital heart disease is the most frequent disease condition associated with congenital hypothyroidism. Congenital heart disease is also reported to be a risk factor for non-autoimmune hypothyroidism in children. In addition, intravenous iodine contrast media is frequently used for diagnostic imaging and therapeutic intervention in congenital heart disease patients. Excess iodine exposed by iodine contrast media may disturb thyroid function in adult and pediatric population. However, there is no generally accepted guideline for screening thyroid dysfunction in congenital heart disease infants. An increased prevalence of thyroid disease, particularly sub-clinical hypothyroidism, has been reported in Down Syndrome. In children with Down Syndrome, a possible concomitant sub-clinical hypothyroidism-related impairment of cardiac function or structure may worsen their clinical condition and can ultimately affect their life expectancy.

NCT ID: NCT03488797 Not yet recruiting - Clinical trials for Congenital Heart Disease

Web-based Motor Intervention to Increase Health Related Physical Fitness in Children With Congenital Heart Disease

Start date: May 2018
Phase: N/A
Study type: Interventional

Children with congenital heart diseases (CHD) often show reduced health related physical fitness as well as limitations in gross and fine motor skills/development. Intervention programs in childhood are still rare and often focus just on the improvement of cardiac outcomes or exercise capacity. Web-based interventions, as a useful alternative to training manuals or supervised training, are cost effective and allow a customization of training times. Primary purpose of this study is to improve health related physical fitness in children with congenital heart disease.

NCT ID: NCT03487302 Recruiting - Clinical trials for Congenital Heart Disease

White Matter Hyperintensities Burden in Adult Patients With Cyanotic Congenital Heart Disease: a Pilot Study

Start date: October 17, 2017
Phase:
Study type: Observational

The study aims at investigating the role of cyanotic congenital heart disease (cCHD) on brain aging. The investigators assume that due to congenital and acquired cardiovascular abnormalities, cCHD patients could show radiologic (and clinical) signs of precocious brain aging and eventual cognitive decline.

NCT ID: NCT03482141 Recruiting - Skeletal Anomalies Clinical Trials

Clinical Utility of Prenatal Whole Exome Sequencing

Prenatal WES
Start date: August 1, 2017
Phase: N/A
Study type: Interventional

The investigator aims to examine the clinical utility of WES, including assessment of a variety of health-related and reproductive outcomes in undiagnosed prenatal cases.

NCT ID: NCT03479957 Not yet recruiting - Clinical trials for Heart Defects, Congenital

Remotely Monitored and Coached Cardiac Rehabilitation Northern Sweden

RECREATION
Start date: May 1, 2018
Phase: N/A
Study type: Interventional

Supervised exercise is an essential component of contemporary center-based cardiac rehabilitation (CR) programs. Despite the proven effectiveness, uptake and adherence to supervised exercise-based CR (exCR) remains suboptimal (approximately 50%), especially in rural and remote areas of Sweden. The main reasons for low participation rate in centre-based exCR are different accessibility barriers i.e. long distances, transportation problems or employment commitments. In this randomised clinical trial, the overall aim is to evaluate the effectiveness of, home-based, remotely monitored and coached exCR using the REMOTE-CR system compared to home-based exCR based on individualized information regarding current exercise recommendations but without monitoring and coaching (usual care) to improve exercise capacity. Our hypothesis is that remotely monitored and coached exCR will improve exercise capacity to a greater extent than home-based exCR without monitoring and coaching (usual care).

NCT ID: NCT03471936 Recruiting - Clinical trials for Congenital Heart Disease

Right Ventricular Diastolic Function in Chronic Adverse RV Loading And Congenital Heart Disease

RaDICAL-CHD
Start date: July 7, 2016
Phase: N/A
Study type: Interventional

The aim of the study is to assess the characteristics, incidence and predictors of load-independent right ventricle (RV) diastolic dysfunction in patients with congenital heart disease (CHD) and adverse RV loading conditions by acquiring pressure-volume loops and compare these results to a population of patients with exclusion of coronary artery disease and absence of any known disease affecting the RV.