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Hypoplastic Left Heart Syndrome clinical trials

View clinical trials related to Hypoplastic Left Heart Syndrome.

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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: NCT00974025 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients

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

In this study, investigators will evaluate the effect of vitamin C on endothelial function, exercise tolerance and quality of life in patients with a single ventricle who have been palliated to Fontan physiology. The hypothesis is that vitamin C will result in improved exercise tolerance and endothelial function in patients who have undergone the Fontan operation, compared to placebo.

NCT ID: NCT00734643 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Family Adaptation Study Following the Diagnosis of Hypoplastic Left Heart Syndrome in a Newborn

Start date: June 2006
Phase:
Study type: Observational

Survival for one of the most complex forms of congenital heart disease, hypoplastic left heart syndrome (HLHS), has improved dramatically. However, little is known about family stress, coping and outcomes following the diagnosis of HLHS. It is expected that families face emotional, social and financial stressors. Health care professionals have a unique opportunity to positively influence how families interpret and adapt to these stressors. The specific aims of the study are to describe perceived stress, and coping skills utilized, in parents of children with HLHS and their impact on family outcomes measured as well-being, adaptation and caregiver/family quality of life, and to describe changes in stress, coping, and adaptation and differences in perceptions of mothers versus fathers of children with HLHS over the first 14 months of life. The Resiliency Model of Family Adjustment and Adaptation (McCubbin, Thompson, & McCubbin, 1996) is the theoretical framework that guides this research. Hypotheses: 1. Family perception of stress, and coping skills utilized, will have an impact on family outcomes measured as well-being, adaptation, and caregiver/family quality of life. 2. Variables influencing perception of stress and variables influencing family coping will be significant predictors of family adaptation outcomes. 3. Perceptions of stress, coping skills utilized, and family adaptation outcomes will improve during the first 14 months of life with an infant with HLHS. 4. Mothers and fathers will report different perceptions of stress, coping skills utilized, and family adaptation outcomes during the first 14 months of life with an infant with HLHS.

NCT ID: NCT00576381 Completed - Clinical trials for Hypoplastic Left Heart

Understanding Dexmedetomidine in Neonates After Open Heart Surgery

Dex
Start date: April 2006
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.

NCT ID: NCT00573066 Completed - Tetralogy of Fallot Clinical Trials

Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery

InfantDex
Start date: May 2004
Phase: Phase 1
Study type: Interventional

This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are breathing with the assistance of a mechanical ventilator or breathing machine.

NCT ID: NCT00571233 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Biomarker Study for Heart Failure in Children With Single Ventricle Physiology

BHFSVP
Start date: February 2007
Phase: N/A
Study type: Observational

The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.

NCT ID: NCT00513240 Completed - Clinical trials for Congenital Heart Disease

Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

Start date: September 2006
Phase: Phase 1/Phase 2
Study type: Interventional

Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.

NCT ID: NCT00507819 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Sildenafil After the Fontan Operation

SAFO
Start date: December 2007
Phase: Phase 2
Study type: Interventional

In this study, the investigators will evaluate the effect of sildenafil on exercise tolerance in patients with a single cardiac ventricle who have undergone the Fontan operation. The investigators will also evaluate echocardiographic measures of ventricular function and measure quality of life changes using two validated quality of life measures. The hypothesis is that sildenafil will result in increased exercise tolerance in patients who have had the Fontan operation as compared to placebo.

NCT ID: NCT00464100 Completed - Clinical trials for Hypoplastic Left Heart Syndrome

Near-infrared Spectroscopy (NIRS) Neurodevelopmental Outcomes

NIRS-ND
Start date: March 1, 2006
Phase:
Study type: Observational

We believe that how a baby with Hypoplastic Left Heart Syndrome (HLHS)does after a major open heart operation, measured by things like blood pressure, oxygen saturation, heart rate and others, may have an impact on development. Studying how post-operative condition impacts outcomes may help us to protect babies better when they undergo surgery. This study will look at some of the long-term outcomes of children with HLHS, including both mental development and quality of life. We will use information from your child's medical record to see if early oxygen delivery has an impact on later development.

NCT ID: NCT00399555 Completed - Clinical trials for Congenital Heart Disease

Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome

Start date: November 2006
Phase: N/A
Study type: Observational

There have been many improvements in the care of children with hypoplastic left heart syndrome (HLHS). This has helped these children survive longer. Because these children now live longer, researchers are recognizing developmental disabilities (the children are behind in their thinking or physical activity) in children with hypoplastic left heart syndrome. The purpose of this research study is to help the investigators learn more about developmental disabilities in children with hypoplastic left heart syndrome. During the time of your child's first surgery for hypoplastic left heart syndrome, a monitor was placed on your child's forehead to measure the oxygen levels in the brain. This monitor is called Near Infrared Spectrometry (NIRS). The researchers involved in this study want to know if oxygen levels in the blood vessels of the brain have any effect on developmental disabilities later in life in children with hypoplastic left heart syndrome. The researchers plan to enroll 60 research subjects.