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Heart Defects, Congenital clinical trials

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NCT ID: NCT04534335 Completed - Clinical trials for Congenital Heart Disease

SNOO Smart Sleeper for Infants With CHD

SHHH's
Start date: February 4, 2020
Phase:
Study type: Observational

Study Title The SSSH Study: SNOO Smart Sleeper Use in Post-Operative Infants with Congenital Heart Disease is a single site, cross-sectional, feasibility study of an infant smart sleeper. The Primary Objective is to evaluate the feasibility of collecting and integrating clinical data and SNOO data. The secondary Objective(s) is To assess the feasibility of conducting a future broader trial by evaluating the parents willingness to give parental permission for participation in the use of the SNOO. Research Intervention(s)/ Investigational Agent(s) SNOO Smart Sleeper from Happiest Baby, Inc.There are approximately 300 new infants per year who undergo cardiac surgery at Children's Mercy Kansas City (CMKC) who are 6 months of age and 11kg or less at the time of surgery Sample Size. A maximum of 15 patients will be enrolled for this feasibility study over the study Duration for Individual Participant Length of hospitalization on 4Sutherland, average length of stay for this patient population is 30 days.

NCT ID: NCT04498728 Completed - Clinical trials for Congenital Heart Disease

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

CATCH
Start date: July 29, 2020
Phase:
Study type: Observational [Patient Registry]

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.

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: 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: 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: 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: 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.