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Heart Defects, Congenital clinical trials

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NCT ID: NCT01063712 Completed - Clinical trials for Congenital Heart Disease

Safety and Effectiveness of the Device "Nit-Occlud® PDA-R"

Start date: June 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and the effectiveness of the device "Nit-Occlud® PDA-R" in the percutaneous closure of patent ductus.

NCT ID: NCT01045356 Completed - Clinical trials for Congenital Heart Disease

Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass

Start date: January 2010
Phase: N/A
Study type: Observational

The purpose of this study is to measure blood levels of TXA in children having cardiac surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery. This study will help determine if the current dosing of TXA results in therapeutic blood levels.

NCT ID: NCT01034007 Completed - Clinical trials for Single Ventricle Cardiac Anomaly

A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

Start date: December 2009
Phase: Phase 1
Study type: Interventional

An initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in children with single ventricle anomalies.

NCT ID: NCT01032876 Completed - Clinical trials for Congenital Heart Defects

Cerebral Perfusion During Neonatal Cardiac Surgery

Start date: January 2009
Phase: N/A
Study type: Interventional

Neonates with a congenital heart defect are often in need of early cardiac surgery. In complex congenital heart defects, cardiopulmonary bypass is usually employed, with or without deep hypothermic circulatory arrest (DHCA). The brain is especially vulnerable to ischemic injury, which puts neonates undergoing complex operations at high risk of neurodevelopmental disorders. Selective antegrade cerebral perfusion (ACP) instead of DHCA during these complex operations may contribute to less cerebral damage, but literature is not conclusive on this issue. Therefore, the investigators will perform a randomised controlled trial comparing DHCA and ACP in neonatal aortic arch reconstructions, focusing on cerebral damage and neurological outcome.

NCT ID: NCT01018472 Completed - Clinical trials for Cyanotic Congenital Heart Disease

Probiotics in Infants With Cyanotic Congenital Heart Disease

Start date: November 2009
Phase: N/A
Study type: Interventional

Infants with congenital heart disease have more frequent infections and exposures to antibiotics than healthy infants. It is unknown how congenital heart disease affects the development of bacterial colonization of the intestines. It is also unknown whether probiotics will change the bacteria in the intestine of infants with heart disease to become more like those of healthy infants without heart disease. This pilot trial is designed to address these two questions.

NCT ID: NCT01006629 Completed - Clinical trials for Congenital Heart Disease

Palivizumab for Prevention of Severe Respiratory Syncytial Virus Infection in Russian Children

Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

100 Russian children of 2 years of age and less in high-risk populations (preterm, and/or with heart and lung problems) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.

NCT ID: NCT00994994 Completed - Clinical trials for Congenital Heart Disease

Tranexamic Acid in Pediatric Cardiac Surgery

TXA
Start date: January 2006
Phase: N/A
Study type: Interventional

Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.

NCT ID: NCT00989911 Completed - Clinical trials for Congenital Heart Disease

Endothelin Blockade in Patients With Single Ventricle Physiology

Start date: May 2010
Phase: N/A
Study type: Interventional

Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.

NCT ID: NCT00974688 Completed - Clinical trials for Congenital Heart Defects

Optimizing Health Among Children With Congenital Heart Defects

Start date: July 2009
Phase: N/A
Study type: Interventional

Quality of life and heart health are intimately connected to childhood physical activity participation (PAP). Physical activity is critical to childhood growth, development, learning, socialization, and quality of life and is an essential component of life-long heart health. Research by the investigators of this study and others has shown that low PAP levels are common among children with heart defects, and that these sedentary lifestyles are not related to exercise capacity, medical status or heart function.

NCT ID: NCT00968565 Completed - Clinical trials for Respiratory Insufficiency

Study Using Citrate to Replace Heparin in Babies Requiring Extracorporeal Membrane Oxygenation (ECMO)

Start date: January 2010
Phase: Phase 0
Study type: Interventional

The purpose of this study is to determine the safety and efficacy of citrate to provide anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the patient and increases the risk of patient bleeding.