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Congenital Heart Defects clinical trials

View clinical trials related to Congenital Heart Defects.

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NCT ID: NCT05191654 Completed - Down Syndrome Clinical Trials

Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

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

Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.

NCT ID: NCT03724006 Completed - Clinical trials for Congenital Heart Defects

Impact of Psychoeducation in Quality of Life of Parents With Children With Congenital Heart Defects

Start date: March 7, 2019
Phase: N/A
Study type: Interventional

Congenital heart defects (CHD) are the most common congenital malformations. Despite the progress made in the last decades in diagnosis and treatment, CHD continues to be associated with significant morbidity and mortality. Several studies have shown a reduction in the quality of life (QoL) of parents of children with CHD, which may affect children too. The main research aim is to assess and to understand the impact of a psychoeducational intervention in QoL of parents with newborns with CHD. We are including parents of inpatient newborns in Neonatal Intensive Care Unit (NICU) of UAG da Mulher e Criança - Centro Hospitalar Universitário de São João (CHUSJ) with the diagnosis of non-syndromic CHD, between March 2019 and February 2020. We also included parents of newborns born at CHUSJ with the diagnosis of non-syndromic CHD, not admited in NICU, between September 2019 and February 2020. The inclusion criteria are: I) parents of newborns (up to 28 days) with the diagnosis of non- syndromic CHD; II) newborns hospitalized in CHUSJ; III) parents aged ≥ 18 years. Parents of newborns with other important co-morbidities associated with CHD and those who do not have good understanding and expression in Portuguese will be excluded. Parents will be divided in 2 study groups: INTERVENTION group (I) and CONTROL group (C). Group I will receive a psychoeducational intervention in addition to the usual routines of the Service. Group C will receive the usual routines of the Service. The psychoeducational intervention, which consists of 2 sessions lasting 90 minutes each one, will be performed as soon as possible after inclusion in the study. Participants will be evaluated in three moments: M1 beginning of the study; M2 4 weeks after the intervention (I) or after enrollment (C) and M3 16 weeks after intervention/enrollment. The primary outcome will be parental QoL, which will be evaluated through the World Health Organization Quality of Life-Bref (WHOQOL-Bref). The family impact and the perception of positive contributions will be secondary outcomes. These outcome variables will be assessed by the Impact on Family Scale and the Positive Contributions Scale - Kansas Inventory of Parental Perceptions, respectively. A semi-structured interview will be performed after all quantitative data have been collected. The authors expect to find an increase of QoL and positive contributions and a decrease of family impact in the intervention group comparatively to the control group.

NCT ID: NCT02766998 Completed - Clinical trials for Congenital Heart Defects

Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

Start date: May 16, 2016
Phase: N/A
Study type: Interventional

This is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will be followed until their Stage II palliative procedure.

NCT ID: NCT02615262 Completed - Cardiac Surgery Clinical Trials

Intraoperative Dexamethasone in Pediatric Cardiac Surgery

Start date: December 2015
Phase: Phase 3
Study type: Interventional

Perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. However, data on effects of steroids on clinical outcomes are lacking. Hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.

NCT ID: NCT02555319 Completed - Clinical trials for Congenital Heart Defects

A Feasibility Study to Evaluate the Safety and Short-term Effectiveness of Transcatheter Pulmonary Valve (TPV)

Start date: August 26, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and short-term effectiveness of implantation of Transcatheter Pulmonary Valve (TPV) for the treatment of congenital heart disease with pulmonary valve disease.

NCT ID: NCT02417259 Completed - Clinical trials for Congenital Heart Defects

Near Infrared Spectroscopy in Cyanotic Congenital Heart Disease

Start date: July 2015
Phase:
Study type: Observational

We are conducting a prospective cohort study of 20 children with cyanotic congenital heart disease who are admitted for cardiac surgery. We will record cerebral and somatic near infrared spectroscopy (NIRS) at two sites - forehead and flank regions using the Covidien INVOS™ 5100C Cerebral / Somatic Oximeter. The monitoring will begin one hour pre-operatively (baseline) and continue until 48hours post-operatively. We will also take measurements prior to discharge from hospital. Baseline demographics, physiological and laboratory variables will be recorded. Clinical outcome variables including mortality, duration of intensive care unit (ICU) stay, duration of mechanical ventilation, inotropic support and feed tolerance will also be recorded.

NCT ID: NCT02320669 Completed - Clinical trials for Congenital Heart Defects

Phase 3 Triiodothyronine Supplementation for Infants After Cardiopulmonary Bypass

TRICC-2
Start date: November 2014
Phase: Phase 3
Study type: Interventional

This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery. Funding Source - FDA OOPD.

NCT ID: NCT02232399 Completed - Clinical trials for Congenital Heart Defects

Is Levosimendan Superior to Milrinone Regarding Acute Kidney Injury After Cardiac Surgery for Congenital Heart Disease?

MiLe-1
Start date: October 15, 2014
Phase: Phase 2
Study type: Interventional

The aim of the study is to assess the ability of Levosimendan to reduce the postoperative acute kidney injury in pediatric patients undergoing surgery for congenital heart disease (CHDs).

NCT ID: NCT01941576 Completed - Tetralogy Of Fallot Clinical Trials

Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot

Start date: September 1, 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

NCT ID: NCT01845402 Completed - Clinical trials for Chronic Kidney Failure

Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease

PRECARDIO
Start date: April 2, 2013
Phase: N/A
Study type: Observational

The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.