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Heart Defects, Congenital clinical trials

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NCT ID: NCT04496050 Active, not recruiting - Clinical trials for Congenital Heart Disease

Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns

EOPTOPWT
Start date: May 6, 2019
Phase:
Study type: Observational [Patient Registry]

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).

NCT ID: NCT04453761 Active, not recruiting - Clinical trials for Congenital Heart Disease

Thiamine Influenced on Substrate Energy Effectiveness in Indonesian Children Undergoing Cardiopulmonary Bypass

Start date: July 1, 2018
Phase: Phase 4
Study type: Interventional

This is a randomized, double-blind, controlled trial design. It was conducted with a main purpose of evaluating the effect of thiamine supplementation on serum lactate and lactate-pyruvate ratio after surgery as direct indicators of tissue perfusion and indirect markers of energy substrate availability for effective mitochondrial function and intubation time as clinical outcome.

NCT ID: NCT04452188 Active, not recruiting - Clinical trials for Cardiopulmonary Bypass

Targeting Normoxia in Neonates With Cyanotic Congenital Heart Disease in the Intra-operative and Immediate Post-operative Period

T-NOX
Start date: January 18, 2021
Phase: N/A
Study type: Interventional

This clinical trial is studying the use of different levels of oxygen exposure during and after cardiopulmonary bypass in eligible infants to learn about its safety during heart surgery. In addition to having the various doses of oxygen, patients that participate will also have blood samples, ultrasounds of the head, and brain wave patterns monitored. The hypotheses of this trial are: - that there will be no difference with regards to adverse events between the infants in the normoxia group compared to the infants in the standard of care group - there will be a significant difference in the measured partial pressure of oxygen (PaO2) values between the two treatment groups. - the use of normoxia during cardiopulmonary bypass and in the immediate post-operative period will result in clinically significant decrease in oxidative stress as measured by thiobarbituric acid reactive substances (TBARS) after cardiac surgery

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: NCT04278625 Active, not recruiting - 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.

NCT ID: NCT04236479 Active, not recruiting - Clinical trials for Congenital Heart Disease (CHD)

Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)

Start date: July 29, 2020
Phase: Phase 1
Study type: Interventional

The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life

NCT ID: NCT04130243 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

Biomarkers in Pediatric Congenital Heart Disease and PAH

Start date: December 5, 2017
Phase:
Study type: Observational [Patient Registry]

Nowadays, biomarkers are broadly used in clinical practice. Blood-derived biomarkers fulfil an important role in the field of cardiology. However, most biomarkers have been investigated for adult left ventricular disease. In congenital heart diseases (CHD) and pulmonary arterial hypertension (PAH), which involves children and mostly the right ventricle, less is known about the clinical and predictive value of blood-derived biomarkers. Since the group of survivors of CHD and PAH is growing because of the improved techniques nowadays, development of better tools to maintain the quality of life for the longer term in these patients is urgently needed. Blood-derived biomarkers are minimally invasive biomarkers, are quantitative and have shown to be able to reveal pathological processes in an early stage. Hence, blood-derived biomarkers may be a good addition to current diagnostic means in CHD and PAH. Objective: The primary objective of this study is to investigate cross-sectionally the association between various emerging blood-derived biomarkers and right ventricular (RV) function:defined as tricuspid annular plane systolic excursion (TAPSE) measured with echocardiography, in children with (a history of ) an abnormally loaded, volume and/or pressure loaded, right ventricle associated with CHD and/or PAH.

NCT ID: NCT03871881 Active, not recruiting - Clinical trials for Heart Defects, Congenital

Impact of Congenital Heart Disease on Neurodevelopmental Outcome

Start date: July 1, 2017
Phase:
Study type: Observational

The project aims toward clarifying the underlying mechanism and the long-term impact of congenital heart disease on neurodevelopment.

NCT ID: NCT03642405 Active, not recruiting - Depression Clinical Trials

Drug-induced Repolarization ECG Changes

Start date: August 15, 2018
Phase:
Study type: Observational

Studies have shown that the risk of developing heart arrhythmias, is increased in patients receiving medication for Attention-deficit hyperactivity disorder (ADHD) and depression. The QT-interval on a electrocardiogram (ECG) is often used to assess the patients risk of developing heart arrhythmias. The QT-interval defines the hearts electrical resting period and a long interval is linked to an increased risk of developing heart arrhythmias. In this project the investigators wish to examine possible side-effects in patients receiving medication for ADHD and depression and their dynamic QT-interval changes, by analysing the ECG changes that occur during "Brisk Standing".