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Heart Defects, Congenital clinical trials

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NCT ID: NCT05140343 Recruiting - Clinical trials for Congenital Heart Disease

Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children

Start date: April 7, 2021
Phase: N/A
Study type: Interventional

The objective of this project is to evaluate the capability of a specific mobile electrocardiogram monitoring of detecting arrhythmic events in children with history of palpitation and or syncope. We will compare this approach with the standard approach of clinical follow-up plus 24-hour Holter ECG monitoring in terms of acceptability and ability to identify significant arrhythmias.

NCT ID: NCT05129631 Recruiting - Clinical trials for Congenital Heart Disease

HEARTPrep: A Virtually-delivered Psychosocial Intervention for Mothers Expecting a Baby With Congenital Heart Disease

HEARTPrep
Start date: July 14, 2023
Phase: N/A
Study type: Interventional

Congenital heart disease (CHD) is the most common birth defect and is increasingly diagnosed prenatally. Mothers describe their prenatal experiences as highly stressful and traumatic after a diagnosis of CHD. Maternal stress during pregnancy exerts a powerful influence on birth outcomes and developmental trajectories, particularly for children in underserved populations. In partnership with diverse parent and clinician stakeholders, our team designed HEARTPrep, an innovative, virtually-delivered psychosocial intervention for mothers expecting a baby with CHD. This project will pilot HEARTPrep with mothers expecting a baby with CHD to obtain preliminary data for a larger future trial. This intervention has the potential to improve emotional wellbeing in mothers expecting a baby with CHD, thereby altering developmental trajectories for this large population of children.

NCT ID: NCT05128084 Recruiting - Clinical trials for Congenital Heart Disease in Children

Amotosalen and Platelet Transfusion in Pediatric Heart Surgery

TransPédia
Start date: October 1, 2020
Phase:
Study type: Observational

High level of security during blood transfusion has been achieved by donor selection and pathogen detection using serology or direct identification. Nevertheless, blood banking becomes hazardous during epidemic outbreaks or facing new pathogens. Amotosalen, a psoralen, targets nucleic acids and destroys them after ultraviolet exposure, resulting in inactivation of pathogens. Treatment inoccuity and efficacy have been demonstrated but preservation of platelet functions after treatment is still debated. Previous studies focused on hematological patients. There is no evidence for an increased requirement of transfused platelets to achieve platelet count target. Studies in heart surgery are lacking. The investigators perform a multicenter, retrospective, "before/after", controlled study in minor patients requiring heart surgery with cardiopulmonary bypass. One center (Strasbourg) uses Amotosalen-treated platelet concentrates since 2006 (control arm). This treatment becomes available in Bordeaux in October 2017 (intervention arm). There is two periods of inclusion: one "before" (January 2016 to June 2017) and one "after" (January 2018 to June 2019).

NCT ID: NCT05122962 Recruiting - Clinical trials for Congenital Heart Disease

Pathophysiologic Mechanism for Arrhythmias and Impaired Aerobic Capacity in Tetralogy of Fallot and Other Congenital Heart Diseases

PACT
Start date: November 1, 2021
Phase:
Study type: Observational

This study is being done to determine the mechanism(s) contributing to the onset of symptoms (i.e. shortness of breath and/or palpitations) as well as changes in heart structure in patients with congenital heart disease (CHD)

NCT ID: NCT05118152 Completed - Clinical trials for Congenital Heart Disease

Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle

VU3D
Start date: June 1, 2021
Phase:
Study type: Observational

Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex. As a result of the improved patient care over the last decades, the number of children and adults with single ventricle is increasing significantly. Today, the main challenge is to ensure an optimal follow-up of these new patients in order to improve their life expenctancy as well as their quality of life (QoL). Currently, echocardiography and cardiopulmonary exercice test (CPET) are central in management of patients with single ventricle as part of good clinical practice guidelines. Single ventricle volumes and function are very difficult to asses with conventional echocardiography because of their complex geometry. Indeed, single ventricle size and morphology vary depending on the patient characteristics and on the initial CHD (before surgical repair). That's why conventional 2D echocardiographic parameters are not reliable for single ventricle assessment. Magnetic resonance imaging (MRI) is more effective in assessing single ventricle volumes and function. Nevertheless, MRI is not universally available, is not practical in many situations, is expensive, and is a relative contraindication in patients with pacemakers. Over the past decade, the use of the 3D echocardiography has increased. This is an available tool that can assess ventricular function and volumes in few seconds. Recent studies shown a good correlation between 3D echocardiography and MRI for assessment of ventricular volumes and function in patient with CHD and especially in those with single ventricle. Moreover, according to some authors, CPET parameters are strongly correlated with risk of hospitalization, risk of death, physical activity and quality of life, especially in patients with single ventricle. To date, there is no study performed about the relationship between 3D echocardiography and CPET parameters in patients with single ventricle.

NCT ID: NCT05109806 Recruiting - Quality of Life Clinical Trials

Psychological Functioning of Children and Adolescents With CHD andTheir Parents, An Intervention Based Study

CHDPIM
Start date: May 7, 2021
Phase: N/A
Study type: Interventional

Almost 1% of infants are born with Congenital Heart Disease (CHD), an umbrella term referring to a range of anomalies in the heart's structure that are present at birth. Owing to significant medical advances, it is now estimated that more than 90% of persons born with CHD will reach adulthood. Children with CHD and their families' mental health outcomes need for psychosocial care. This study will intend to improve the psychological functioning of children, adolescents with CHD and their parents. The research will comprise of two major studies. The sample of first study will be based on a Cohort (From April 2021 to October 2021) of children, adolescent and their parents. Participants will be assessed for their psychological functioning and health related quality of life using Strength and Difficulty Questionnaire, pedsQL 3.0 cardiac module , Parental Stress Index , and 36-Item Short Form Survey. It is hypothesized that parental psychological functioning will mediate the relationship between psychological functioning of children and adolescent with CHD and their health related quality of life. It is also hypothesized that emotional behavioral issues of children and adolescents will moderate the link between parental psychological functioning and their quality of life. Illness parameters and sociodemographic correlates will serve as covariates in the study. This study will provide a baseline for the second study that is expected to use a randomized control trial of an intervention program based on training workshops derived from CHIP for the reduction in parental distress, emotional behavioral problem and improvement in health related quality of life among children, adolescent with CHD and their parents. The pretest-posttest design will be used. The randomized control trial will be conducted as per Consort Guidelines. A sub sample will be selected from the initial study using purposive sampling. Intervention study will include a subsample of CHD population (60 children and adolescents each) and their parents using purposive sampling technique. The participants will be randomly assigned to experimental & control groups. Illness related and demographic parameters will be distributed equally in both groups for establishing control. The intervention will be administered to experimental group only, while control group will receive regular treatment. Results of Pretest and posttest measures will be statistically analyzed. The designed intervention program (using problem solving therapy, psycho-education and Parenting the child with CHD training) will lower the level of parental stress in parents and emotional behavioral issues in CHD population. It will further increase the level of health related quality of life among children and adolescent with CHD and their parents. The research will incorporate psychosocial care with CHD population along with their regular treatment and thus improve their future health related outcomes in Pakistan.

NCT ID: NCT05105880 Completed - Clinical trials for Congenital Heart Disease

Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

Start date: January 1, 2018
Phase:
Study type: Observational

The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.

NCT ID: NCT05103774 Not yet recruiting - Clinical trials for Value of Thyroid Functions in Children With Congenital Heart Diseases

Thyroid Functions in Children With Congenital Heart Diseases

Start date: December 1, 2021
Phase:
Study type: Observational

Thyroid hormone is critical for normal neurocognitive development in young infants, and even transient hypothyroidism can cause adverse neurodevelopmental outcomes. In a population of infants with CHD who already bear a high risk of long-term developmental delay, detection of hypothyroidism, even of a transient nature, may be even more consequential, and routine periodic monitoring of thyroid function may be necessary to reduce the risk of neurodevelopmental disabilities

NCT ID: NCT05101746 Enrolling by invitation - Clinical trials for Congenital Heart Disease

Nitric Oxide Effect on Brain and Kidney in Pediatric Patients Undergoing Cardiopulmonary Bypass

Start date: April 25, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The goals of this study are: 1. To evaluate the neuroprotective effect of nitric oxide by measuring glial fibrillary acid protein (GFAP) before and after surgery. GFAP will be analyzed via an enzyme-linked immunosorbent assay (ELISA) kit. Patients will also be monitored post-operatively for delirium in the intensive care unit (ICU). 2. To evaluate the renal protective effect of nitric oxide by measuring neutrophil gelatinase-associated lipocalin (NGAL) before and after surgery. NGAL will also be analyzed via an ELISA kit. Patient creatinine will be monitored post-operatively. 3. To evaluate effect of nitric oxide on other ICU outcomes (invasive mechanical ventilation, days to extubation, ICU and hospital length of stay, and blood product administration).

NCT ID: NCT05090306 Recruiting - Clinical trials for Congenital Heart Disease

Interpretation of Fetal Echocardiography by Artificial Intelligence

LIFE
Start date: November 1, 2020
Phase:
Study type: Observational

The study to be performed aims to design and develope an automated Intelligent Decision Support System for fetal echocardiography that can significantly assist the obstetric physician in the improvement of detection of fetal congenital heart disease compared to the common standard of care.