Active clinical trials for "Heart Defects, Congenital"

Problem: With the increased survival rate of children with congenital heart disease, other health problems, in addition to the clinic, have emerged, such as the risks of developmental delay to which these children are exposed. There is a need for low-cost intervention studies that seek to minimize these risks. Objective: To evaluate the effect of an early stimulation program using parents as vectors of intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk for developmental delays according to the guidelines of the American Heart Association (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, direct with the researcher through videos, and messages via cell phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the applicability of the protocol will be administered to the parents of the intervention group Expected results: Better neuropsychomotor performance in children after applying the early stimulation protocol. Perspectives: Create a body of information that can serve as a basis for the formulation of policies for intervention and surveillance of the development of this population.

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.

Tranexamic acid is a relatively safe medicine that is used to help the body develop clots and slow down bleeding after large surgeries. While it has already been shown to work well in adults and older children, there is no information on whether it works, and how it works in children younger than 6 months old. The goal of our study is to try and understand whether and how tranexamic acid works in children younger than 6 months old who are having open heart surgery. We plan to study tranexamic acid by testing its effect when compared with a placebo. The investigators will use a method called randomization - which means patients who agree to be in the study will be entered into a computer. The computer will randomly assign them to either receive the medicine or the placebo. We will then compare effects on the 2 groups of patients. Our goal is to have 50 patients in each group, or 100 patients total. We will not know whether patients receive tranexamic acid or placebo until we review the data collected at the end of the study. Tranexamic acid is usually given to patients in the operating room during open heart surgery. During open heart surgery patients require cardio-pulmonary bypass which is a machine that replaces the function of the heart and lungs for a short period of time. This allows surgeons to do surgery on the heart itself without having to worry about it moving during the operation. The bypass machine has lots of tubes to carry the blood around it. When blood comes into contact with the tubing it has a tendency to clot. To prevent this patients are given a blood thinner called heparin. Although heparin prevents clotting in the bypass machine, it can also increase the risk of bleeding when the surgery is over. To reduce this risk patients are given another medicine at the completion of surgery called protamine to try and reverse the effect of the blood thinner, heparin. Even so bleeding remains a significant problem, especially for babies after open heart surgery. Being on the bypass machine and having a lot of suture (stitches) lines increase that risk. In addition, the bypass machine affects the function of platelets, the main component of the body's clotting system. We often have to replenish blood products after surgery to try and stop the bleeding. Some centers, including we , have used the medicine tranexamic acid to try and help with bleeding after surgery. There have been other studies that show it helps with fibrinolysis, which is another important part of the body's clotting system. However, that part of the clotting system is not well developed in infants and therefore likely does not play an important role in preventing bleeding in that age group. As such, it may be that tranexamic acid impacts platelet function as well, and it is that effect that helps decrease post-operative bleeding in infants younger than 6 months. This has not been previously studied. In order to study the effect that tranexamic acid has on platelets the investigators are proposing the investigators' research trial. The investigators plan to randomize patients to either receive tranexamic acid or placebo in the operating room as described above. The investigators will then draw a small amount of blood from each patient (total of approximately 1 tablespoon) and send it to a special lab for testing of platelet function. The lab test will help us understand whether the platelets function better when patients receive tranexamic acid instead of placebo. The investigators will also be monitoring other outcomes related to platelet function. These will include how much bleeding patients have after surgery when they are in the intensive care unit, and how much blood products they require to treat that bleeding. The investigators will also monitor labs that are checked routinely in all patients after open heart surgery. The investigators will also track how long it takes each patient to get off the ventilator and how long they spend in the ICU after surgery. All of this data will help us understand whether tranexamic acid makes a positive impact on outcomes after open heart surgery in infants less than 6 months old. The current standard of care is quite variable within our institution as well as at other institutions. Some anesthesiologists use tranexamic acid while others elect not to. There is no definitive guideline to its current use. The dosing differs from center to center, and there are some centers that do not use it at all. The investigators' hope is that the results of this study will help us understand the role tranexamic acid plays in preserving the function of platelets after open heart surgery in young infants, and whether that impact translates into improved outcomes for those patients. Based on the results of our research we hope to develop definitive guidelines for the use of tranexamic acid in the population of infants <6 months old undergoing open heart surgery.

In adolescents with congenital heart disease physical activity level is reduced which is why promotion to a more active lifestyle with an age-appropriate and modern intervention is needed. In healthy subjects digital health nudging was shown to increase physical activity. However, in adolescents with congenital heart disease such studies have not been conducted yet. In this RCT participants receive daily, short smartphone messages with the primary purpose to increase daily physical activity, which is monitored with a "Garmin vivofit jr." wearable.

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

The purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they might be employed to patient caries -prevention treatment.

The goal of this clinical trial is to analyze implications of two alternative nudge-interventions to increase adherence to palivizumab prophylaxis in children with congenital heart disease. The main questions investigators aim to answer are: Are well-established cognitive biases effective in increasing patient families' adherence to the palivizumab prophylaxis program? What are the factors that affect families' adherence to the prophylaxis program and whether and how the effects of interventions depend on these factors? To study these questions investigators planned to utilize four well-established cognitive biases in designing two alternative nudge-interventions and investigators measured the effectiveness of each nudge-intervention against a control group. Patients were randomly allocated to one control and two treatment groups. In the control group, investigators informed participants about the prophylaxis program and provided a schedule. Patients in the first treatment group were additionally called two days before appointments (status quo bias), and were asked to plan the appointment day (implementation intention). Patients in the second treatment group received biweekly messages informing them about the benefits of the program as well as the current adherence rate (availability bias and social norm).

In 2012, infants having surgery for congenital heart disease have a high survival. The investigators are now focused on improving how sick these infants become after surgery (short term outcomes) and their later neurodevelopment (long term outcomes). During heart surgery, cardiopulmonary bypass (CPB; the heart-lung machine) takes over heart function while the surgeon repairs the heart disease. During this surgery there are periods of time when the amount of blood going to the heart and brain is lower than usual, called "ischemia". Once the surgery is finished the blood going to the heart and brain is increased to normal again, called "reperfusion". This ischemia-reperfusion can cause injury to the heart, brain, and other organs, affecting the short and long term outcomes in these infants. Adult studies have shown that a short time of ischemia to the legs for 5-10 minutes [the legs are not damaged by a short time of ischemia, unlike the heart or brain], before severe ischemia to another distant vulnerable vital organ [like the heart or brain], can protect this other vital organ from ischemia-reperfusion injury. This is called "remote ischemic preconditioning" (RIPC). Our objective is to test whether RIPC before heart surgery can improve the recovery of the heart and brain after heart surgery in newborn babies with congenital heart disease. The investigators will test whether RIPC will result in lower peak lactate and troponin levels on the day after heart surgery. Lactate levels are a marker for how much the different tissues of the body suffer from ischemia-reperfusion injury. Troponin is released from damaged heart during ischemia-reperfusion. In our trial infants will be randomized to RIPC or control. This means each baby has an equal chance of being in one group or the other. The intervention group will have RIPC before surgery; the "control group" will not. The investigators hope this trial will lead to a larger study to test if RIPC results in fewer days on a breathing machine after surgery, lower mortality, and higher scores on neurodevelopmental tests at 2 years of age.

Background: - Currently, heart catheterization procedures are guided by X-rays. Researchers are developing new techniques to perform heart catheterization without the use of X-rays by investigating possible uses of magnetic resonance imaging (MRI) scans. To study these uses, researchers are interested in performing a part of the standard X-ray catheterization procedure using MRI on individuals who are scheduled to have heart catheterization. Objectives: - To examine the safety and feasibility of right-heart catheterization using MRI-guided catheters. Eligibility: - Individuals at least 21 years of age who are undergoing a medically necessary heart catheterization procedure. Design: The research MRI procedure will be performed either before or after standard X-ray guided heart catheterization. Participants will be transferred from an X-ray table onto an MRI table and advanced into the scanner. Under MRI guidance, a MRI-compatible catheter will be used to measure blood pressure and blood oxygen levels in the heart, and MRI scanning will be performed for approximately 30 minutes.

The aim of the study is to assess the ability of Levosimendan to reduce the postoperative acute kidney injury in pediatric patients undergoing surgery for congenital heart disease (CHDs). Young children, between the age of 1 to 12 months, with congenital heart disease in need of elective heart surgery will be included in this study. The trial will contain two study groups, 35 patients in each. One group will receive Levosimendan and the second group will receive Milrinone as a heart muscle-strengthening agent during and after the operation. Milrinone is currently used as the drug of choice in many pediatric cardiac surgery centers. It remains to see if Levosimendan can exert a kidney protecting function in addition to its heart muscle-strengthening properties. The primary objective of this study is to investigate the preventive effect of Levosimendan on postoperative acute kidney injury in pediatric patients undergoing surgery for their CHDs. Creatinine levels postoperatively will be the primary endpoint. Creatinine, the common marker of kidney injury, will be measured daily. The treatment with Levosimendan or Milrinone will be started during the operation (after initiation of cardiopulmonary bypass) and will last 24 hours. Blood samples will be obtained at six occasions perioperatively. Patients will be followed 4 days after termination of treatment (totally 5 days). The duration of study will be 30 days (24 hours treatment + 4 days follow up + 30-days-mortality registration). Creatinine is the primary outcome in this study. Inflammatory biomarkers and other relevant biomarkers will comprise the secondary outcome variables.