Active clinical trials for "Heart Defects, Congenital"

The purpose of this study is to explore the feasibility of implementing nurse-led music therapy in a cohort of neonates admitted to the Cardiac Intensive Care Unit (CICU) post congenital heart surgery. In the proposed setting, the use of a standardized nurse-led music therapy protocol for post-operative neonates would build upon current successful nurse-led efforts to wean sedatives and opioid use for patients admitted to the CICU. The investigators believe data generated from this exploratory feasibility study may serve to further inform a larger study involving the use of music therapy in the cardiac intensive care.

Over the past four decades, it has become clear that childhood physical activity carries with it a myriad of beneficial effects. It is closely linked to quality of life and the recognized benefits include, but are not limited to, optimal growth and development, a healthier self-concept, enhanced peer socialization, and decreased anxiety and depression. Long term, an active lifestyle decreases the risk of many important physical and mental morbidities. Thus, the observation that children living with medical conditions and disabilities (MC&D) today, although surviving longer thanks to advances in medical care, are much less active than their peers is a matter of significant concern. Research indicates that the 350,000 Ontario children with MC&D have lower levels of physical activity, higher screen time and more frequent sleep problems. While the reasons underlying this reality are complex, previous research has identified a substantial subset of children who are motivated to be active but lack the confidence to do so. Fear of pain, concern for MC&D exacerbation and a lack of confidence in individual physical movement capacity contribute to their hesitation. Clinical experience suggests that these children represent 50% to 70% of inactive patients. Research indicates that being motivated to make a change and having the confidence that the desired change can be achieved are the essential precursors upon which successful behaviour change initiatives are built. This randomized, controlled trial will explore whether group sessions with a Registered Kinesiologist lead to a direct bolstering of physical activity confidence, and in turn to increased and sustained physical activity in these children. Such an approach holds the promise of a nonpharmacologic, low cost and accessible means of enhancing health that shall be met with a high level of patient and family support while bringing a significant societal and medical return on investment.

The objective is to the amount of protein infants require after cardiopulmonary bypass surgery.

The aims of this study were to evaluate the long-term effectiveness of the Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program, on improving disease knowledge and physical activity in youth with congenital heart disease (CHD). The COOL program is a 12-month randomized controlled trial that compared two active intervention groups to a standard-care control group (n = 47). Participants with simple and moderate CHD aged 15-24 years were recruited from pediatric or adult CHD outpatient departments. Participants in one active intervention group (n = 49) were provided with COOL Passport, a mobile healthcare application. Those in the other group (n = 47) were provided with access to the Health Promotion Cloud system and use of game-based interactive platforms along with COOL Passport. Outcomes were the Leuven Knowledge Questionnaire for CHD and the International Physical Activity Questionnaire-Taiwan Show-Card Version.

The purpose of this study is to pilot test an innovative, guided participation (GP) intervention to help parents develop competencies in communication for parenting an infant with a complex congenital heart defect (CCHD) through the first six months of age.

Infants with congenital heart disease often require an intervention during their first year of life. Infants are generally admitted to a cardiac intensive care unit and are routinely prescribed stress ulcer prophylaxis to decrease acid release from the stomach to prevent stress ulcer formation. However, these medicines may not be safe and could put infants at increased risk for hospital-acquired infections, necrotizing enterocolitis and alteration to the infant's microbiome. The investigators plan to assess the feasibility of conducting a prospective, blinded randomized control trial to determine the safety of withholding stress ulcer prophylaxis in critically ill infants with congenital heart disease. In addition, the investigators plan to examine the changes to the infant's microbiome through oral, gastric and stool samples and compare hospital-acquired infections.

Infants with congenital heart disease (CHD) are usually born with a normal weight but develop malnutrition over time, and about 20-50% of these children are usually malnourished. Malnutrition in these patients is multifactorial. To compensate for the increased need for infants and children with CHD, an increase in their caloric intake has been suggested. However, these patients may not be able to receive enough to meet the increased needs and catch-up growth. One of the suggested solutions in these patients to compensate for inadequate food intake is to increase the caloric density of milk or formula. For this purpose, the use of special formulas with higher calorie density or enrichment of normal formula or breast milk using special enrichment formula could be suggested. In the present study, the effect of increasing calorie intake by increasing the concentration of normal formula in comparison with formula with standard concentration on weight gain and other anthropometric indices of CHD patients with malnutrition will be compared.

The Effect of Individualized Nutrition Training Given to the Families of Children with Congenital Heart Disease (CHD) in the Post-Operative Period on their Growth and Development This study was conducted experimentally to determine the effects of individualized nutrition training given to mothers of children who had surgery for CHD on their growth and development.

This study is part of a larger research project known as Swedish Transition Effects Project Supporting Teenagers with chrONic mEdical conditionS (STEPSTONES). This project was created to develop and evaluate transition programs in order to support adolescents with chronic conditions in Sweden. While STEPSTONES has a generic nature, the first transition program that will be evaluated targets adolescents with congenital heart disease (ConHD). This particular study involves a hybrid experimental design, meaning a randomized controlled trial is embedded in a longitudinal, observational study. This type of design will help to test the effectiveness of a transition program in order to empower adolescents with congenital heart disease in the transition to adulthood and check for potential contamination of the comparison group. We will recruit 210 participants: 140 adolescents will be part of the randomized controlled trial (70 in the intervention arm; 70 in the comparison arm), and 70 participants will be assigned to the observational, longitudinal arm of the study, which serves as control group in an intervention-naive center. Over a period of two years, three assessments will be done during which all participants will be asked to answer a set of questionnaires. The intervention to be tested involves patient empowerment, education on their ConHD, dealing with school, health behaviors required to maintain good health, guidance of parents, a person-centered transition plan, among others. The study hypothesis is that adolescents with ConHD who received a structured, person-centered transition program over a 2-year period have a higher patient empowerment score than adolescents who receive usual care.

This study will conduct an initial clinical evaluation of this support program to examine its impact on reducing caregiver stress, increasing confidence in daily feeding, and improving weight-for-age growth percentiles in infants with Congenital Heart Disease (CHD).