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Heart Defects, Congenital clinical trials

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NCT ID: NCT06295575 Completed - Clinical trials for Congenital Heart Disease

Effect of Probiotics on Patients With Congenital Heart Disease Following Cardiopulmonary Bypass

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

A randomized, controlled study including infants with non-cyanosis congenital heart disease (CHD) in need of surgical correction involving cardiopulmonary bypass (CPB) was established. Infants aged 1 month to 1 years were enrolled between June 2021 and July 2022. The patients in treatment group were supplied with probiotics consisting of Bifidobacterium infantis and Lactobacillus perioperatively and patients in control group were provided with placebo. Data concerning patients' clinical outcome such as diarrhea were collected. Blood samples were collected for measurement of fatty acid binding protein 2 (FABP2), diamine oxidase (DAO), d-lactic acid (D-LA) and C-reactive protein (CRP). Stool samples were collected to investigate the changes of intestinal flora.

NCT ID: NCT06292910 Completed - Clinical trials for Congenital Heart Disease

Central Venous to Arterial CO2 Difference and Low Cardiac Output Syndrome Related Outcomes in Children After Cardiac Surgery

VACO2
Start date: August 8, 2021
Phase:
Study type: Observational

The goal of this clinical trial is to compare the capability of 3 different bedside surrogates in children who underwent cardiac surgery and were admitted in intensive care unit. These test are lactate, oxygen saturation from central venous and the carbon dioxide gap between central venous and arterial. The main questions is which one is the best prognostication for post operation poor outcomes Participants will be taken routine blood test for post cardiac care (at ICU arrival, 6, 12, and 24 hour post operation) and follow the their outcomes. There is no any intervention or drug in this research

NCT ID: NCT06186258 Completed - Clinical trials for Congenital Heart Disease

Infective Endocarditis in Percutaneous Pulmonary Revalvulation: Comparison Between Melody and Sapien Valves

Endopulm
Start date: December 17, 2021
Phase:
Study type: Observational

Percutaneous pulmonary valve revalvulation (PPVR) has emerged as an alternative to surgery for the treatment of congenital heart disease with right ejection pathway dysfunction. The Melody valve (Medtronic Inc., Minneapolis, Minnesota) was the first to be used, validated in 2006 by the European Commission and in 2010 by the Food and Drug Administration (FDA). Subsequently, the Sapien valve (Edwards SAPIEN pulmonic transcatheter heart valve, Edwards Lifesciences, Irvine, California) was subsequently approved for PPVR (Europe, 2010; FDA 2016). Infective endocarditis (IE) after PPVR is currently a major concern with an incidence after Melody PPVR estimated at 3%, much higher than the rate of prosthetic left-heart IE. The Sapien valve has been introduced more recently and some cases of IE have been published. Despite the attention this issue is receiving, there are few studies of sufficient size or statistical power to elucidate the risk factors for developing an IE after PPVR according to the type of valve implanted. Recently, a multicenter study was published by the American team of McElhinney et al (J Am Coll Cardiol 2021 ; 78 :575-589). Although it was a sizeable cohort (2476 patients), there was a large disparity in the ratio of patients who underwent revalvulation with either the Melody or Sapien valve, in favor of Melody patients (2038 Melody patients vs. 438 Sapien patients). In this study, the estimated risk of IE was higher for patients who received a Melody valve, according to univariable analysis but not anymore after multivariate analysis. To further answer this question, we develop an international retrospective multicenter registry whose main objective will be to characterize the incidence rate of infective endocarditis after percutaneous pulmonary revalvulation according to the type of valve implanted (Melody vs. Sapien) using a large population of patients with comparable characteristics (match-population).

NCT ID: NCT06168344 Completed - Quality of Life Clinical Trials

The Effect of Web-based Training Given to Mothers of Babies With Congenital Heart Disease

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

This study was assessed the impact of a web-based education program provided to mothers of infants with congenital heart diseases on their quality of life and self-efficacy levels. The study is a mixed-method approach with a qualitative and pre-test post-test design, utilizing randomized controlled quasiexperimental type. The research was conducted with mothers of infants diagnosed with congenital heart disease who sought care at the Pediatric Cardiology Outpatient Clinic of a university hospital and were followed up. There are two groups in the study. Web-based education was provided to mothers in the intervention group (n=30). No intervention was applied to the mothers in the control group (n=30) other than the outpatient clinic routine of the hospital.

NCT ID: NCT06107491 Completed - Depression Clinical Trials

Preoperative Educational Videos on Maternal Stress Whose Children Received Congenital Heart Disease Surgery: During COVID-19 Panic

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

During COVID-19 panic, we examined if educational digital video disk can reduce maternal uncertainty, anxiety and depression if their children undergo congenital heart disease surgery and when surgical or post-surgical complications occur. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more after education, and until the day of discharge. Compared to only routine education, adding digital video disk could decrease mothers' uncertainty and anxiety more on the discharge day if their child had surgical or post-surgical complications.

NCT ID: NCT05976204 Completed - Clinical trials for Congenital Heart Disease

Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome

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

Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained <14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.

NCT ID: NCT05945459 Completed - Malnutrition, Child Clinical Trials

The Effect of High-Calorie Formula on Nutritional and Clinical Outcomes Among Infants After Congenital Heart Surgery

Start date: February 14, 2018
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effect of high-calorie density formula (HDF) and standard formula (SF) in infants with congenital heart surgery. The main questions it aims to answer are: 1. Is there any difference in nutritional status between both groups after 3 months? 2. Is there any difference in calorie intake per day between both groups during hospitalization? 3. Is there any difference in clinical outcomes (mortality, duration of using mechanical ventilation, length of stay, and events of side effects) between both groups? A group of participants will be given HDF (1 kcal/ml) from enrollment until three months. Researchers will compare them to the group of participants who are given SF (0.67 kcal/ml) to see if there is any difference in nutritional status, calorie intake, and other clinical outcomes between the two groups.

NCT ID: NCT05934578 Completed - Quality of Life Clinical Trials

Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

Background: The Fontan operation has been used to treat complex cardiac anomalies with a single-functioning ventricle. A study performed by Instituto do Coracão-Hospital das Clínicas-Universidade de Sao Paulo (InCor/HCFMUSP)-Brazil, Hospital das Clínicas of Ribeirão Preto-Brazil, department of the University of Aarhus, and Rigshospitalet, Denmark demonstrated an impairment peripheral lymphatic function in Fontan patients compared with healthy controls. However, the ability to increase the frequency of contractions is impaired when stressed by hyperthermia. Lymph vessels in Fontan patients were unable to respond usually. The participants were only able to increase the frequency of contraction twice during stress, compared to a five-fold increase among healthy controls. At the microcirculation level, Fontan patients filtered less fluid into the capillaries interstitial space than healthy controls at venous occlusion pressure. Studies carried out at InCor/HCFMUSP demonstrated that supervised aerobic exercise training improves the functional capacity and neurovascular control in Fontan patients compared to the non-training control group. However, the effect of aerobic exercise and light muscle resistance performed through online rehabilitation has not yet been demonstrated in peripheral lymphatic function and microcirculation. Aim: Evaluate the effects of an aerobic and light muscle resistance exercise program on peripheral lymphatic function, capillary filtration, functional capacity, and quality of life in adults with Fontan circulation. Methods: The function of the superficial lymphatic vessels in the lower leg will be investigated during rest in supine and standing positions, using near-infrared fluorescence imaging using Indocyanine Green (ICG; Verdye, Diagnostic Green GmbH, Germany). The variables analyzed are contraction frequency (contraction/minute), pumping Pressure (mmHg), and packet velocity. Venous congestion plethysmography will perform to analyze the capillary filtration and cardiopulmonary exercise test for functional capacity. The quality of life will be evaluated using the SF-36 Short-Form questionnaire. Expected results: the physical training improves peripheral lymphatic function, capillary filtration, functional capacity, and quality of life in patients with biventricular compared to the control group (no exercise training)

NCT ID: NCT05853263 Completed - Surgery Clinical Trials

Morphine IV vs Paracetamol IV in Neonates and Infants After Cardiac Surgery

PACS
Start date: March 9, 2016
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare pain management in neonates and infants under 3 years of age undergoing cardiac surgery with use of cardiopulmonary bypass. Patients will be randomized to either continuous morphine IV (standard) of intermittent paracetamol IV (intervention). The investigators' hypothesis is that intermittent IV paracetamol is effective as the primary analgesic drug in post-cardiac surgery patients up to 3 years of age and that the use of IV paracetamol will reduce overall morphine requirements.

NCT ID: NCT05800691 Completed - Clinical trials for Cyanotic Congenital Heart Disease

Predicting Factors for Mortality in Congenital Heart Disease Patients After Shunt Procedure in Developing Country.

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

Blalock Taussig (BT) is a palliative procedure that preserves blood circulation to the lungs and alleviates cyanosis in patients with congenital heart diseases and reduced pulmonary blood flow. BT shunt remains a routinely performed procedure in developing countries before definitive surgery. However, evidence on predictors factors of mortality after this procedure is still scarce in Indonesia.