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Heart Defects, Congenital clinical trials

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NCT ID: NCT04354220 Active, not recruiting - Critical Illness Clinical Trials

Capnography Monitoring in Ventilated Children

Start date: June 9, 2020
Phase:
Study type: Observational

End-tidal CO2 measurements in children will be assessed for their accuracy with arterial CO2 measurements.

NCT ID: NCT04336384 Completed - Covid-19 Clinical Trials

Impact of Covid-19 in Congenital Heart Disease

COVID-CHD
Start date: March 1, 2020
Phase:
Study type: Observational

The ongoing Coronavirus (Covid-19) pandemic has recently generated the first epidemiological data on populations at risk. Currently, the risk factors, recognized for severe forms of Covid-19 infection, are elderly patients (> 70 years), obese patients, patients with chronic renal or respiratory diseases, cardiovascular history (stroke or coronary artery disease), high blood pressure, diabetes, and cancer. The population of congenital heart disease (CHD) might also be at risk, however, no data is available in this group of patients. CHD is the leading cause of birth defects, and as a result of recent medical advances, currently the number of adults with CHD exceeds the number of children, with an increasing prevalence of complex CHD. Approximately 200,000 children and 250,000 adults are living with a CHD in France today. The French Society of Cardiology, coordinator of this study, issued recommendations on March 14, 2020 for the French CHD population on the basis of expert opinions based essentially on the data published in the general population. Nevertheless, there is a need to provide scientific data on the impact of Covid-19 in the pediatric and adult CHD population. This study aims to assess the morbidity, the mortality and the risk factors associated with Covid-19 in patients with CHD in France

NCT ID: NCT04324957 Completed - Clinical trials for Congenital Heart Defect

Neonatal Cardio-Pulmonary Outcome Measure

N-COM
Start date: August 31, 2020
Phase:
Study type: Observational [Patient Registry]

Neonatal Cardio-Pulmonary outcome measure (N-COM) will be used to assess the overall status of pulmonary and cardiac vascular system of neonates in Neonatal Intensive Care Unit (NICU). There are many scales available which are helpful for assessing behavior, pain, and neurological status of neonates but there is no scale available till now which can help to assess cardio-pulmonary status of neonates.

NCT ID: NCT04315610 Recruiting - Clinical trials for Stress, Psychological

Personalized Mobile App for Parents of Infants With Cardiac Disease

HOBS
Start date: June 1, 2021
Phase: N/A
Study type: Interventional

This project implements an eHealth intervention targeted at vulnerable infants with cardiac disease and specifically study how this intervention impact their parents coping, stress levels and personal wellbeing. The intervention will be evaluated through a randomized controlled trial (RCT). The aim of this project is therefore to measure if the features of this mobile application are useful for parents' assessment of deterioration, decision-making and communication with health care providers.

NCT ID: NCT04307030 Recruiting - Clinical trials for Congenital Heart Disease in Children

Study on AI Recognition System Of Heart Sound In Congenital Heart Disease Screening

Start date: July 1, 2020
Phase:
Study type: Observational

The objective of this study is to establish AI algorithm based on the deep learning to strengthen the ability to classify the heart murmurs of healthy people and different major or other subdivided congenital heart diseases(CHDs) and to evaluate the effectiveness of artificial intelligence technology-assisted heart sound recognition system (referred to as: Heart sound AI recognition system) for multi-center CHD screening.

NCT ID: NCT04299828 Recruiting - Clinical trials for Congenital Heart Disease

Evaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery

Start date: May 31, 2022
Phase:
Study type: Observational

The goal of this proposal is to prospectively collect data from a series of 100 patients (all ages) undergoing complex cardiac surgical procedures involving cardiopulmonary bypass (CPB) to: 1. Measure the number of blood activated circulating monocytes before, during and after cardiac surgery and serum GABA and pro-inflammatory cytokine levels 2. Understand the correlation between GABA and inflammatory cytokines (and/or activated monocytes) and 3. Assess the correlation between thrombosis and monocyte activation in patients undergoing cardiac surgery under CPB and at risk of thrombosis.

NCT ID: NCT04295239 Completed - Clinical trials for Congenital Heart Disease in Children

Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery

NEMOCARD
Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Cardiac surgery under extracorporeal circulation (ECC) in newborns with congenital heart disease causes significant morbidity and mortality. The perioperative period is a period of major vulnerability implicated in the appearance of these sequelae, and it is therefore essential to monitor brain function during ECC. The quality of cerebral oxygenation in the perioperative period is routinely monitored non-invasively by infra-red spectroscopy, which makes it possible to estimate cerebral tissue oximetry from a surface electrode (NIRS). The association between time spent outside the limits of cerebral self-regulation and the occurrence of perioperative encephalopathy is not known. The purpose of this study is to determine whether disturbances in brain self-regulation during the operative period are associated with the occurrence of postoperative encephalopathy in children operated on for congenital heart disease in the neonatal period. The main objective of the research is to determine the association between time spent outside individually determined cerebral self-regulation limits and the appearance of brain lesions suggestive of low brain output. Secondary objectives will investigate the association between time spent outside self-regulatory limits and the occurrence of postoperative encephalopathy defined by clinical and encephalographic criteria and will study factors predictive of the development of postoperative encephalopathy.

NCT ID: NCT04292483 Recruiting - Clinical trials for Congenital Heart Disease

Pulmonary Capillary Recruitment in Fontan Patients

Start date: June 11, 2020
Phase:
Study type: Observational

This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of 3H-benzoyl-Phe-Ala-Pro (BPAP). FCSA will be related to flow and other hemodynamic parameters in order to determine if there is capillary recruitment or distention in Fontan patients. We will also compare baseline FCSA measurements with previously studied normal subjects, to assess the difference in hemodynamic pulmonary functional parameters between these single ventricle physiology patients and normal subjects.

NCT ID: NCT04278625 Completed - Clinical trials for Congenital Heart Disease

Pharmacokinetics of Acetaminophen in Pediatric Patients With Congenital Heart Disease

Start date: March 23, 2021
Phase:
Study type: Observational

This is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. These levels will be used to develop a pharmacokinetic model. Serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the Fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.

NCT ID: NCT04271358 Active, not recruiting - Clinical trials for Congenital Heart Disease

Peer Coaching Intervention in Young Adults With Congenital Heart Disease

CHASM in ACHD
Start date: October 8, 2020
Phase: N/A
Study type: Interventional

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