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Heart Defects, Congenital clinical trials

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NCT ID: NCT01603732 Completed - Clinical trials for Congenital Heart Disease in Pregnancy

Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease

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

The goal of this study is to find out if there is any association between a mother's exposure to bacteria that normally causes "strep throat" and her baby's developing heart disease/heart defect.

NCT ID: NCT01598441 Completed - Clinical trials for Pulmonary Hypertension

Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects. It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.

NCT ID: NCT01595386 Completed - Clinical trials for Heart Disease Congenital Complex

Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

Start date: April 2012
Phase: N/A
Study type: Interventional

This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.

NCT ID: NCT01572363 Completed - Clinical trials for Congenital Heart Disease

Fontan Patients: Comprehensive Evaluation of Pulmonary Circulation and Ventricular Function

Start date: April 2012
Phase: N/A
Study type: Interventional

In patients with one anatomical or functional ventricular chamber, which encompasses a spectrum of rare and complex congenital cardiac malformations, a staged surgical approach in view of an ultimate Fontan operation has become the procedure of choice. Especially in the earlier era, perioperative mortality was the leading cause of death. However, many patients have a long and high-quality life, continuously improved by a better understanding of Fontan hemodynamics and the refinement of the surgical procedures. Nevertheless, the prospect of eventual failure of the Fontan circulation remains a major concern. More specifically, evaluation of the pulmonary circulation becomes particularly important as the failing Fontan circulation has become a common indication for cardiac transplantation. Although essential, especially in the preoperative setting, a comprehensive evaluation of the pulmonary circulation remains difficult in this patient population Our global hypothesis is that the absence of pulsatile pulmonary flow may lead to the development of pulmonary vascular lesions after the Fontan operation and that - together the absence of a subpulmonary ventricle for pressure generation - this increasing afterload will result in systemic ventricular underfilling and will eventually lead to a failing Fontan circulation.

NCT ID: NCT01570933 Completed - Surgery Clinical Trials

Feasibility Study Over the NAVA Mode in Noninvasive Ventilation After Cardiac Surgery in Infants.

NIVNAVA
Start date: November 2011
Phase: Phase 4
Study type: Interventional

Neonates who underwent cardiac surgery with cardiopulmonary bypass almost always require non-invasive respiratory support (NIV) in relay to conventional ventilation. Current nasal interfaces do not generally allow synchronised bilevel ventilation. NIV-NAVA mode allows, through an oesophageal catheter, to record the electrical activity of the diaphragm and thereby synchronize breaths from the ventilator on the inspiratory efforts of the child. Moreover, the pressure support delivered by the ventilator may be proportional to the diaphragmatic effort developed by the child. This mode, associated with the interface Miniflow®, could increase the comfort of the child by allowing a more efficient synchronization and reducing its respiratory work. To our knowledge, this ventilation mode with this interface has not been evaluated in the postoperative period of cardiac surgery in the newborns. The purpose of this study is to evaluate the feasibility of this ventilatory mode and evaluate its influence on ventilatory parameters of this category of infants.

NCT ID: NCT01567579 Completed - Clinical trials for Congenital Heart Defects

An Evaluation of Routine Developmental Follow-Up in Infants and Children With Congenital Heart Disease

Start date: September 2009
Phase:
Study type: Observational

The purpose of this study is to understand how having a heart problem affects development,quality of life, and family life in young children and their families. Results for children and families with heart disease will be compared to children and families without heart disease. The investigators hope that this information may help us to support children and families better in the future. All children and families that are seen in the HHC Developmental Follow-Up Program will be asked if they would like to take part in this study. It is hypothesized that children with congenital heart disease will demonstrate developmental delays when compared to normative values.

NCT ID: NCT01562574 Completed - Clinical trials for Acquired Bleeding Disorder

Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

Start date: January 2002
Phase: Phase 3
Study type: Interventional

This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.

NCT ID: NCT01548950 Completed - Clinical trials for Pulmonary Arterial Hypertension

Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to test the hypothesis that treating PAH-CHD patients preoperatively with PAH drugs and keeping them on treatment for six months after surgery reduces the risk of immediate postoperative death and the risk of residual PAH at six months following operation to <10%.

NCT ID: NCT01531985 Completed - Clinical trials for Congenital Heart Disease

Urine and Serum Biomarkers for Early Detection of Acute Kidney Injury

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

The purpose of this study is to find out whether a combination of new urine tests and blood tests can show kidney injury in its early stages, before kidney failure sets in. If the investigators find new tests that show kidney injury in early stages, the investigators hope to start treating people with kidney injury earlier, to prevent kidney failure. You/your child are at higher risk for kidney injury and kidney failure than most other people, because of having operations with cardiopulmonary bypass (a machine that pumps your/your child's blood during the operation). This research is being done because there are no tests yet proven to show kidney injury before it leads to kidney failure. The urine and blood tests the investigators are studying have each been shown to indicate some degree of kidney injury in certain people, but not with the accuracy needed to diagnose disease. The investigators think that the combination of urine and blood tests being tried in this research study may provide enough information to better diagnose kidney injury at an earlier stage. About 20 persons over 2 years old up to adults will take part in this study. All will be from the Herma Heart Center of Children's Hospital of Wisconsin.

NCT ID: NCT01503307 Completed - Clinical trials for Congenital Heart Disease

Parenting After Infant Congenital Heart Defect Diagnosis

Start date: January 2009
Phase:
Study type: Observational

The purpose of this research study is to learn about parents' experiences following diagnosis of a fetal/neonatal Congenital Heart Defect (CHD). Nurses, physicians, and other health-care clinicians will benefit from an improved understanding of what the diagnosis means to parents and what they expect concerning the infant, being a parent, and caregiving tasks and responsibilities. The investigators expect that the knowledge gained will increase clinicians' ability to respond to parents' needs.