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Heart Defects, Congenital clinical trials

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NCT ID: NCT04454294 Completed - Clinical trials for Congenital Heart Disease

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

Start date: July 28, 2018
Phase: N/A
Study type: Interventional

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.

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: NCT04452201 Completed - Communication Clinical Trials

Parent Communication for Feeding an Infant With a Heart Defect

Start date: February 25, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to pilot test an innovative, guided participation (GP) intervention to help parents develop competencies in communication for parenting an infant with a complex congenital heart defect (CCHD) through the first six months of age.

NCT ID: NCT04452188 Completed - 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, participants 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: NCT04437069 Recruiting - Clinical trials for Congenital Heart Disease

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

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04434001 Terminated - Clinical trials for Congenital Heart Disease

ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery

ZEPLAST-PED
Start date: February 27, 2020
Phase: Phase 2
Study type: Interventional

In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significant impact on outcome. Fresh frozen plasma (FFP) for bleeding management is associated, particularly in this kind of patients, to volume overload and a significative increase of Transfusion Related Acute Lung Injury (TRALI), further worsening the postoperative outcome. In the adult patient FFP employment could be almost completely canceled by administration of concentrated hemostatic components - the fibrinogen concentrate and prothrombin complex concentrate (PCC). We designed this phase II pilot study to establish whether an analogous strategy, modified accordingly to pediatric physiology, could be safely and successfully applied in newborns and infants.

NCT ID: NCT04416230 Completed - Clinical trials for Congenital Heart Disease

Post-Op Massage in Infants With Congenital Heart Disease

Start date: May 1, 2012
Phase: N/A
Study type: Interventional

The primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including parental anxiety, severity of cardiac defect, and severity of pain. Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between two groups over time: infants receiving post-operative massage seven days post-operatively and infants receiving a comparable time of restricted non-essential caregiving seven days post-operatively. Specific Aim 2: To compare pain scores and physiologic responses before and after intervention in two groups: infants receiving post-operative massage and infants receiving a comparable time of restricted non-essential caregiving. Specific Aim 3: To examine potential moderators of pain response in the massage intervention group before and after receiving massage.

NCT ID: NCT04413071 Completed - COVID-19 Clinical Trials

Cardiac COVID-19 Health Care Workers

CCC
Start date: May 25, 2020
Phase:
Study type: Observational

The study will analyze the prevalence of cardiac involvement of health care workers from the University Hospital of Salamanca (HUSA) who have overcome SARS-CoV-2 infection. Participants will undergo a clinical evaluation, electrocardiogram (EKG), cardiac magnetic resonance (CMR) and blood analysis including NT-proBNP, troponin, cellular and humoral immunity and genetics.

NCT ID: NCT04382573 Recruiting - Clinical trials for Congenital Heart Defects

Better Delineation of CDK13 Related Phenotype and Epigenetic Signature.

CDK13
Start date: November 1, 2019
Phase:
Study type: Observational

CDK13 related disorder is mainly characterised by developmental delay (DD) and intellectual disability (ID), ranging from mild to severe, and malformation syndrome. The aims of this study are first to better delineate the clinical phenotype, as well as the neuropsychological profile, and the brain MRI characteristics; and, second, to study the epigenetic signatures in a cohort of individuals with CDK13 intragenic pathogenic variants. This work will conduct to a MD thesis of a clinical resident geneticist in France. Physician that will participate will fill an Excel sheet regarding the clinical and neuropsychological assessment. The investigators will be also happy to have either CD-ROM or a link to have access to the brain MRI data as well as a DNA sample with a minimum 0.5ug of peripheral blood genomic DNA. The investigators will gather the DNA in Montpellier genetic lab (Dr Mouna BARAT) and send the batch to the Dr Sadikovic' lab. Between 2019 and 2020, The investigators have already recruited data from individuals with CDK13 pathogenic variants from France and several European genetic centres.

NCT ID: NCT04382222 Not yet recruiting - Clinical trials for Congenital Heart Disease in Pregnancy

Prenatal Screening for Congenital Heart Diseases in the Antwerp Region

SEC
Start date: June 1, 2020
Phase:
Study type: Observational

No systematic research has been done in the last 15 years on the accuracy of prenatal ultrasound of congenital heart diseases in Belgium. Nor are there any population-based studies available on this subject for Belgium. Based on the data of EUROCAT (European Surveillance of Congenital Anomalies) the investigators analyse prenatal diagnostic sensitivity of congenital heart diseases in the EUROCAT regions Antwerp (Flanders, Belgium)