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Heart Defects, Congenital clinical trials

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NCT ID: NCT03348397 Completed - Clinical trials for Congenital Heart Defect

Contegra Versus Pulmonary Homograft for Right Ventricular Outflow Tract Reconstruction in Newborns

Start date: March 1, 2017
Phase: N/A
Study type: Observational

Pulmonary homografts are standard substitutes for right ventricular outflow tract reconstruction in congenital heart surgery. Unfortunately shortage and conduit failure secondary to early calcifications and shrinking are observed particularly for small sized conduits in younger patients. In neonates, Contegra® 12mm could be a valuable alternative, but conflicting evidence exists. This retrospective study compared the outcome of these two conduits in a newborn population.

NCT ID: NCT03335475 Recruiting - Physical Activity Clinical Trials

Congenital Heart Disease Physical Activity Lifestyle Study

CHD-PALS
Start date: October 5, 2017
Phase: N/A
Study type: Interventional

This study will adapt a physical activity lifestyle intervention to adolescent congenital heart disease (CHD) survivors with the primary goal of increasing physical activity levels. The study will be split into 2 phases. In Phase 1, participants will be asked to complete questionnaires, wear an accelerometer around the waist for 7 days, and undergo an exercise stress test. The accelerometer and exercise stress test will be used to determine whether participants are eligible to be randomized for the intervention study. A parent will be asked to complete questionnaires at baseline as well. In Phase 2, participants will be randomized to one of two conditions: 1) receiving a physical activity tracker (a Fitbit) or 2) receiving a Fitbit AND engaging in videoconferencing sessions with a physical activity coach. During Phase 2, participants will also be asked to complete 2 assessments (weeks 9 and 22). The week 9 assessment will consist of completing questionnaires and wearing an accelerometer for 7 days. Week 22 will be similar to week 9 with the addition of a final exercise stress test. The same parent will be asked to complete questionnaires at the final assessment as well. Participants who are randomized to the videoconferencing condition will be asked to meet with a physical activity coach 8 times over the course of 20 weeks. Coaches will help participants to (1) change attitudes toward physical activity, (2) increase perception of others' approval of physical activity (e.g., family members, peers), and (3) increase participants' perceived control by troubleshooting barriers and increasing efficacy for physical activity. Coaches will use the Fitbit to facilitate self-monitoring and goal setting.

NCT ID: NCT03329170 Recruiting - Dental Caries Clinical Trials

Improved Oral Health and Dental Care in Children With Congenital Heart Disease

ORALPEDHEART
Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Background: Congenital heart disease (CHD) is one of the most common congenital anomalies in children. As the risk for endocarditis following bacteraemia is more common during daily oral hygiene routines, such as tooth brushing, than during dental treatment, the maintenance of optimal oral health in children with CHD may be considered of outmost importance. Children with CHD have a higher caries prevalence compared to healthy controls. Aim: The primary aim of the study is to explore if an educational intervention including information, counselling and support provided at early stage to families affected by major CHD, or CHD combined with a syndrome, can increase the awareness of the importance of maintaining of good oral health, and avoid the development of poor oral health including dental caries, leading to less dental anxiety and a higher oral heath related quality of life. The secondary aim is to elucidate factors associated with the development of poor oral health and/or orofacial dysfunction as well as family attitudes and needs of support. Hypothesis: Early information, counselling and support will lead to a) increased awareness of the importance to maintaining good oral health, b) prevent the development of poor oral health and dental caries, c) lead to less dental fear, and d) lead to higher oral heath related quality of life. Study design: Randomized educational intervention trial. Study population: Children born in Finland and under 6 months of age in 1.7.2017-31.12.2019 with, a) major CHD and potentially included in the criteria of endocarditis prophylaxis, or b) with a major CHD combined with a chromosomal syndrome, will be offered to participate in the study. Patients will be recruited until 200 patients are obtained at the Helsinki University Children's Hospital. A control group consisting of approximately 100 healthy children will also be recruited at birth. Main outcomes: Dental caries, dental anxiety, oral health related quality of life, and awareness of importance to maintain and behaviour to maintain good oral health. Significance: Better information to patients leads to better possibility to achieve good oral health. Better oral health leads to 1) less dental procedures and thereby less dental anxiety, 2) less dental procedures under general anaesthesia, which may potentially be a risk procedure for the child with CHD, and 3) better oral health related quality of life.

NCT ID: NCT03311438 Completed - Dental Plaque Clinical Trials

Oral Health Intervention Program for Children With Congenital Heart Defects

Start date: September 1, 2009
Phase: N/A
Study type: Interventional

Background: Children with congenital heart defects (CHD) are reported to have poorer oral health compared with healthy children. The aim of the present study was to evaluate the effect of an intensive oral health care program among children with CHD followed from infancy to the age of five years, by comparing their oral health status at five years with a control group of children with CHD who had not received the program. Methods: In this longitudinal study, children in western Norway with a need for lifelong follow-up due to congenital heart defects were invited to participate (n=119). Children born in 2008-2011 were offered a promotive oral health intervention program from infancy to the age of five years. The outcome measures for evaluating the intervention were dental caries prevalence, dental erosion, plaque index and gingival bleeding index. The data of the intervention group were compared with cross sectional oral health data of five year old controls with CHD born 2005-2007 (already published).

NCT ID: NCT03303248 Not yet recruiting - Clinical trials for Congenital Heart Disease

Evaluation of Web-based Transition Education to Enhance Transition Readiness

Start date: December 2017
Phase: N/A
Study type: Interventional

The study looks to learn more about the helpfulness of web-based transition education and its effect on transition readiness and health service utilization in the adolescent and young adult congenital heart disease population.

NCT ID: NCT03297658 Recruiting - Clinical trials for Congenital Heart Defect

Electro-acupuncture (EA) in Children Undergoing Procedures for Congenital Heart Defects.

Start date: November 15, 2017
Phase: N/A
Study type: Interventional

This is a single site, randomized, blinded, sham controlled, parallel group study to identify whether electro-acupuncture (EA) is a beneficial anesthesia adjunct in children undergoing procedures on their congenital heart defects (CHD).

NCT ID: NCT03275844 Not yet recruiting - Clinical trials for Heart Defects, Congenital

Physical Capacity and Activity in Children With Congenital Heart Disease

Start date: November 1, 2017
Phase: N/A
Study type: Observational

Congenital malformations correspond to defects in organ morphogenesis identifiable at birth or intrauterine life, affecting 2-3% of births. Inside of these malformations, Congenital Heart Disease corresponds, in particular, to structural defects of the heart or major blood vessels thereof may or may not be associated with other types of syndromes.The resolution is usually surgical. Also, these patients present a decrease in physical fitness, psychological imbalance, lower quality of life and risk significant morbidity and mortality from respiratory infections among other problems. This can have severe consequences for health in the medium and long term. The habits acquired during childhood and adolescence are determinant for the adult life, being relevant levels of activity and physical condition, especially in children with pathologies. In this way, it is vital to know from childhood parameters that indicate the baseline state of these patients according to the levels of physical activity, exercise capacity, nutritional status and quality of life. These will be key indicators to take into account in the future, to adapt rehabilitation plans that will reduce the effects of their condition. The objective of this protocol is To characterize the levels of Activity, and Physical Capacity of children with congenital heart disease regularly treated at the Cardiovascular Center of Dr. Luis Hospital Calvo Mackenna, compared to healthy children matched by age and sex.

NCT ID: NCT03262168 Recruiting - Heart Diseases Clinical Trials

Supported Exercise Programme for Adults With Congenital Heart Disease

SEACHange
Start date: June 2, 2017
Phase: N/A
Study type: Interventional

This study will evaluate if the introduction of a supported exercise programme can improve physical and psychological well-being for adults with congenital heart disease.

NCT ID: NCT03255850 Recruiting - Clinical trials for Congenital Heart Disease

Psychological Well Being and Quality of Life of Adolescents Congenital Heart Disease Patients in Hong Kong

Start date: August 15, 2017
Phase: N/A
Study type: Observational

This study aims to examine the psychological well-being and QoL of Hong Kong Chinese adolescents with CHD by - comparing the self-esteem level, depressive symptoms, and quality of life of adolescents suffering from CHD with healthy norms and cancer survivors. - identifying possible factors affecting the quality of life of adolescents suffering from CHD.

NCT ID: NCT03248830 Not yet recruiting - Clinical trials for Congenital Heart Disease

Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

Start date: October 20, 2017
Phase: N/A
Study type: Observational

The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.