300,000+ clinical trials. Find the right one.

106 active trials for Congenital Heart Disease

Determining the Effect of Two Different Methods in Children to Maintain Drain Patency After Cardiac Surgery

In this study, it was aimed to determine the effect of the use of milking and sucking methods on bleeding amount, vital signs and oxygen saturation in children with chest and mediastinal drains after cardiac surgery.

Start: August 2020

Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise

Each year world-wide, 2.5 million fetuses die unexpectedly in the last half of pregnancy, 25,000 in the United States, making fetal demise ten-times more common than Sudden Infant Death Syndrome. This study will apply a novel type of non-invasive monitoring, called fetal magnetocardiography (fMCG) used thus far to successfully evaluate fetal arrhythmias, in order to discover potential hidden electrophysiologic abnormalities that could lead to fetal demise in five high-risk pregnancy conditions associated with fetal demise.

Start: July 2018

Cardiac Acute Transitioning Care to Home (CATCH) App Data Repository

This repository will consist of clinically derived data and images of patients with congenital heart disease from the time of birth until they have reached one of the following outcomes: transition to outpatient care that has not resulted in readmission in 30 days after hospital discharge, death, weaned off supplementary feeding tubes, or clinic visits demonstrating clinical stability with their primary cardiologist, or full bi-ventricular cardiac surgery palliation with improvement in hemodynamic stability. This information will be collected for clinical evaluation and diagnostic purposes and will continue to be stored for potential future research application.

Start: July 2020

Healthcare Transition of Adolescents With Chronic Health Conditions

At least 12% of children have a chronic disease that requires regular medical follow-up after patients reach legal maturity. This international study aims to provide prospective evidence for improving health and wellbeing outcomes in this population. The primary hypothesis is that transition readiness will be more strongly associated with adherence to follow-up, fewer emergency visits and continued education than disease severity or chronological age. The secondary hypothesis is that positive experiences of care will be associated with lower levels of anxiety. Positive care experiences and low anxiety will predict better health-related quality of life during the transition period. A cohort of 504 young patients will be followed for three years. Patients have been recruited from pediatric hospitals 0-12 months prior to the transfer of care and follow-up will be completed after the patients have been followed for two years in adult healthcare.

Start: September 2017

Protecting Brains and Saving Futures - the PBSF Protocol

Background: Multiple neonatal disorders are associated with risks of neurological injury. Thus, management of these infants should involve a coordinated approach to permit early diagnosis with improved clinical care. Such initiative involves the use of standardized protocols, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG (aEEG) and Near Infrared Spectroscopy (NIRS), neuroimaging and training. Brazil is a very large country with disparities in health care assessment; some neonatal intensive care units (NICUs) are not well structured and trained to provide adequate neurocritical care. However, the development and implementation of these neurocritical care units requires high expertise and significant investment of time, manpower and equipment. In order to reduce the existing gap, a unique advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) protocol was developed and implemented in some Brazilian NICUs. Methods: A prospective observational cohort study will be conducted in 20 Brazilian NICUs that have adopted the PBSF protocol. All infants receiving the protocol during January 2021 to December 2023 will be eligible. Ethical approval will be obtained from the participating institutions. The primary objective is to describe the use of the PBSF protocol and clinical outcomes, by center and over a 3 years period. The use of the PBSF protocol will be measured by quantification of neuromonitoring, neuroimaging exams and sub-specialties consultation. Clinical outcomes of interest after the protocol implementation are length of hospital stay, detection of EEG seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, and referral of patients to high-risk infant follow-up. These data will be also compared between infants with primarily neurologic and primarily clinical diagnosis. Discussion: The implementation of the PBSF protocol may provide adequate remote neurocritical care in high-risk infants with optimization of clinical management and improved outcomes. Data from this large, prospective, multicenter study are essential to determine whether neonatal neurocritical units can improve outcomes. Finally, it may offer the necessary framework for larger scale implementation and help in the development of studies of remote neuromonitoring.

Start: January 2021

Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making

This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.

Start: October 2020

Dopamine Versus Norepinephrine Under General Anesthesia

Participants under general anesthesia will be randomly treated with an adjusted dose dopamine or norepinephrine to elevate 10% of mean arterial pressure. Systemic hemodynamic data is recorded by PRAM and the change of cardiac index is compared between groups.

Start: October 2020

Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

The purpose of this research is to evaluate and create a new clinical prediction model for CCHD screening that combines non-invasive measurements of oxygenation and perfusion.

Start: October 2019

Use of a Predictive Analytics Algorithm to Optimize Weaning of Inotropes Following Pediatric Cardiac Surgery

The objective of this study is to determine the effectiveness of a real time continuous risk analytics algorithm in the successful de-escalation of vasoactive and inotropic support in pediatric patients following cardiac surgery.

Start: January 2021

Ocular and Vision Problems in Patients After Fontan Operation

The purposes of this study are to identify indicators of vision problems and ocular abnormalities in patients with a Fontan circulation through a standardized questionnaire and to correlate the intraocular pressure measured with the Icare tonometer with central venous pressure measured with the VENUS 2000 CVP non-invasive system to determine whether intraocular pressure can be used as a surrogate measure of increased central venous pressure in patients with a Fontan circulation.

Start: February 2016

Peer Coaching Intervention in Young Adults With Congenital Heart Disease

The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.

Start: October 2020

Evaluating Right Ventricular (RV) Size and Function Using the Upper Valley RV Algorithm and Novel Imaging Modalities

The primary purpose of this study is to evaluate the diagnostic performance of three methods for measuring right ventricular size and function including the Philips Novel RV quantification technologies (RV Heart Model volumetric analysis and Philips 2D strain) and the Upper Valley Right Ventricle Algorithm (UVRV) algorithm as compared to the gold standard of volumetric analysis via cardiac magnetic resonance imaging (CMR) in a broad patient population.

Start: August 2019

Tetralogy of Fallot for Life

The aim is to conduct a prospective multi-centre international inception cohort study with an enrollment goal of 3,000 TOF patients and 2 year follow-up post-repair. The proposed sample size and methodology will result in statistically powerful results to allow for evidence-based change to current TOF surgical practices.

Start: June 2015

Better Mechanistic Understanding of and Risk Stratification for Ventricular Tachyarrhythmias Through ECGI

This study aims to evaluate the electrophysiological properties of the heart conduction system in patients with (increased risk of) ventricular tachyarrhythmias (VTA) and sudden cardiac arrest, and in a control cohort. The electrophysiological properties will be measured with the relatively new technique ECG-Imaging (ECGI). Moreover, clinical data of subjects will be gathered. By combining the data from the data gathering and the results of ECGI, the investigators hope to increase mechanistic understanding of and risk stratification for VTAs. The investigators aim to be able to identify patients at risk of an arrhythmic event, and aim for better treatment strategies in the future.

Start: June 2020

The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS

The primary outcome for this project will be the development of a small, non-invasive wireless sensor that is linked to a conventional computer that can be used in health care for monitoring of acute and chronic health problems. The advantages of developing this technology are threefold. First, monitoring can be conducted for a fraction of the cost of a bedside nurse. Second, monitoring can be done in real time and stored so that we can diagnose and manage critical events in a more timely manner. Lastly, many patients can be monitored simultaneously. The wireless sensors will be fitted to healthy volunteers of various ages. The data gathered from the sensor with respect to their vital signs will be compared to that of conventional tools such as nursing assessments and pulse oximetry.

Start: December 2021

Genetics of Congenital Heart Disease

Congenital heart disease (CHD) is the most common type of birth defect but the cause for the majority of cardiac birth defects remains unknown. Numerous epidemiologic studies have demonstrated evidence that genetic factors likely play a contributory, if not causative, role in CHD. While numerous genes have been identified by us and other investigators using traditional genetic approaches, but these genes only account for a minority of the non-syndromic CHDs. Therefore, we are now utilizing whole exome sequencing (WES), with the addition of more traditional genetic techniques such as chromosomal microarray or traditional linkage analysis, to identify genetic causes of familial and isolated CHD. With WES we are able to sequence all of the genes of an individual and apply different data analysis techniques based on whether we are analyzing a multiplex family or a cohort of trios (mother, father and child with CHD) with a specific isolated CHD. Therefore, WES is a robust method for identification of novel genetic causes of CHD which will have important diagnostic and therapeutic consequences for these children.

Start: December 2009

Acute Maternal Hyperoxygenation in CHD

Congenital heart disease (CHD) is predominantly detected before birth. Using echocardiography and MRI, this study will determine whether acute exposure to maternal hyperoxygenation (MH) leads to measurable increases in fetal cerebral oxygenation from baseline in fetuses with CHD. The study aims to determine whether MH could be used as a chronic in-utero treatment strategy to promote brain growth/maturation to birth and to improve postnatal neurodevelopmental outcomes, and identify the types of CHD most likely to benefit from chronic MH.

Start: April 2019

Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study

The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS).

Start: June 2019

Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease

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.

Start: March 2019

Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns

Prostaglandin E1 (PGE1) has been used in the medical treatment of ductal dependent critical congenital heart disease in neonates. Apnea/ bradycardia, hypotension, hypokalemia, feeding difficulties, fever, jitteriness are the most important side effects of PGE1. Also gastric outlet has been reported. We aimed to determine effect of PGE1 treatment on pyloric wall thickness in newborn period. In this study, the side effect of increase of pylorus muscle wall thickness will be monitored with weekly ultrasonography. No intervention in the treatment, medical decisions and follow-up of these patients will be made. After reaching the sufficient number of cases (20 cases), increases in the pyloric wall thickness dimensions will be compared with statistical analysis. The number of cases was determined in accordance with the rate of hospitalization in our unit during the determined period (18 months).

Start: May 2019