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Heart Defects, Congenital clinical trials

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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: NCT05824650 Completed - Frailty Clinical Trials

Frailty and Non-Fragile Congenital Heart Disease

Start date: April 20, 2023
Phase:
Study type: Observational

Congenital heart disease (CHD) is defined as congenital functional or anatomical abnormalities of the heart and intrathoracic great vessels. This study, which is planned to be carried out, will enable people with CHD to present a holistic perspective when planning rehabilitation programs and to create a common language for all health professionals.

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.

NCT ID: NCT05778240 Completed - Clinical trials for Congenital Heart Disease in Children

Adherence to Palivizumab Prophylaxis

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

The goal of this clinical trial is to analyze implications of two alternative nudge-interventions to increase adherence to palivizumab prophylaxis in children with congenital heart disease. The main questions investigators aim to answer are: - Are well-established cognitive biases effective in increasing patient families' adherence to the palivizumab prophylaxis program? - What are the factors that affect families' adherence to the prophylaxis program and whether and how the effects of interventions depend on these factors? To study these questions investigators planned to utilize four well-established cognitive biases in designing two alternative nudge-interventions and investigators measured the effectiveness of each nudge-intervention against a control group. Patients were randomly allocated to one control and two treatment groups. In the control group, investigators informed participants about the prophylaxis program and provided a schedule. Patients in the first treatment group were additionally called two days before appointments (status quo bias), and were asked to plan the appointment day (implementation intention). Patients in the second treatment group received biweekly messages informing them about the benefits of the program as well as the current adherence rate (availability bias and social norm).

NCT ID: NCT05763238 Completed - Quality of Life Clinical Trials

Exercise Training in Children With Corrective Cardiac Surgeries

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

To determine the effects of preoperative exercise therapy on postoperative cardiopulmonary outcomes and quality of life in children with corrective cardiac surgeries.Within literature there is limited evidence on preoperative exercise therapy in the pediatric population, positive results of the study can introduce a new tradition of preoperative exercise therapy and significantly reduce post-operative complications. Secondary complications would also be addressed in the study, a positive result can reduce the total costs by reducing hospital stays and improving the quality of life of child.

NCT ID: NCT05717049 Completed - Clinical trials for Congenital Heart Disease

Theophylline Effects in the Fontan Circulation

THIEF
Start date: February 9, 2023
Phase: Phase 2
Study type: Interventional

A single group treatment phase 2 single-arm no-masking study to assess safety and efficacy of a short-term oral treatment with theophylline (ATC-no. R03D A04) in terms of improvements in cardiorespiratory fitness, health-related quality of life, cardiac performance and respiratory function in male and female adolescents aged 16 to 25 years with a Fontan-type surgical palliation of univentricular congenital heart disease.

NCT ID: NCT05665712 Completed - Clinical trials for Congenital Heart Disease

Pediatric Enhanced Recovery After Cardiac Surgery

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

Identify our institution's current perioperative management strategies for pediatric cardiac surgery patients. Identify predictive factors for receiving perioperative care following P-ERACS strategies. Compare outcomes between P-ERACS and non-P-ERACS patients

NCT ID: NCT05579964 Completed - Clinical trials for Cardiopulmonary Bypass

The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot

Start date: October 10, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Congenital heart disease (CHD) is the most common congenital abnormality found in newborns with Tetralogy of Fallot (TOF) being the most common cyanotic CHD. Total correction of TOF was performed using a cardiopulmonary bypass (CPB) machine. However, the use of CPB has a negative effect that causes inflammation and myocardial injury. Myocardial protection in patients undergoing total correction of TOF surgery is more difficult than other cyanotic CHD due to a hypertrophic right ventricular condition. Dexmedetomidine (DEX) is a selective α-2 adrenergic, which has major effects including hypnosis, sedation, and analgesia as well as cardiovascular effects. The sedation is induced by stimulating the α-2 adrenergic receptor in the locus coeruleus (LC) in the pons cerebri. DEX also increases the level of GABA and Galanin and reduces endogenous norepinephrine. The lower level of endogenous norepinephrine decreases the afterload of the ventricles, increases cardiac output, and reduces myocardial injury as a result. Furthermore, the peripheral effects of DEX can reduce myocardial ischemia-reperfusion (MIR) by inhibiting NF-кB pathway activation and reducing the number of pro-inflammatory cytokines released. Thus, the administration of DEX can prevent myocardial necrosis and apoptosis, also reducing reperfusion injury when using CPB machines. Research related to the effectiveness of administering DEX as a myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery in Indonesia is less reported. The aim of this study is to determine the effectiveness of DEX as myocardial protector in classic TOF patients undergoing elective total correction cardiac surgery.

NCT ID: NCT05546983 Completed - Clinical trials for Congenital Heart Disease in Children

How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?

Pedia-Card
Start date: September 1, 2022
Phase:
Study type: Observational

Congenital heart disease is a common abnormality in newborns. The marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. With the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.

NCT ID: NCT05526768 Completed - Clinical trials for Congenital Heart Disease

Evaluation of VITLS Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children

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

We are seeing how well a remote monitoring device that looks like a sticker placed on the chest, under the arm can monitor a child's vital signs including oxygen levels compared to the way that we usually get these measurements. The goal of this study is to see if the new sticker can be used for monitoring patients with cardiac shunt dependent heart conditions from home once they are discharged home. Participating children will be monitored for 6-72 hours with the new sticker in addition to his/her usual hospital monitors so the new sticker device can be compared to our hospital monitors.