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Heart Defects, Congenital clinical trials

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NCT ID: NCT03757312 Enrolling by invitation - Clinical trials for Congenital Heart Disease

A Pilot Study of Optic Nerve Ultrasound Following Cardiopulmonary Bypass

Start date: December 2018
Phase: N/A
Study type: Interventional

The purpose of the proposed study is to evaluate the incidence of subtle increases in intracranial pressure (ICP) following cardiopulmonary bypass (CPB) using optic nerve sheath diameter (ONSD), measured by non-invasive ultrasound. As direct measurements of ICP are not feasible following CPB, ONSD will be used as a correlate of ICP. ONSD has been shown to be effective in the ICU and emergency room setting for detecting increased ICP and is an accepted standard for such measurements. The primary hypothesis is that changes in ICP occur following CPB without clinically appreciable signs and symptoms. These changes in ICP will be reflected by changes in ONSD. If there is a significant incidence of sub-clinical cerebral edema and increased ICP postoperatively, these findings may impact postoperative hemodynamic and ventilation goals and techniques.

NCT ID: NCT03737006 Recruiting - Clinical trials for Congenital Heart Disease in Pregnancy

Coxsackie Virus in Pregnancy and Congenital Heart Disease

Start date: March 1, 2016
Phase:
Study type: Observational

Investigators would like to find out if a woman's exposure to Coxsackievirus has an effect or increase in incidence of babies being born with congenital heart disease(CHD)

NCT ID: NCT03724006 Not yet recruiting - Clinical trials for Congenital Heart Defects

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

Start date: November 2018
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 will include parents of inpatient newborns in Hospital Pediátrico Integrado - Centro Hospitalar de São João (HPI - CHSJ) with the diagnosis of CHD, between November 2018 and October 2019. The inclusion criteria considered will be: I) parents of newborns (up to 28 days) with the diagnosis of CHD; II) newborns hospitalized in HPI-CHSJ; III) parents aged ≥ 18 years. Parents of newborns with other 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 SF36v2 Health Survey. 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: NCT03690518 Recruiting - Clinical trials for Heart Defects, Congenital

Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases

QUALIREHAB
Start date: July 27, 2018
Phase: N/A
Study type: Interventional

The investigators aim to measure the impact of a rehabilitation program in congenital cardiology in terms of health related quality of life. The orginality of the rehabilitation program consists in its design : initial hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the supervision of a specialized sports trainer.

NCT ID: NCT03690245 Not yet recruiting - Clinical trials for Hypoplastic Left Heart Syndrome

Initiation of Resuscitation While Attached to the Cord With Congenital Heart Disease

INSPIRE-CHD
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Before birth, the placenta (a structure with many blood vessels attached to the inside of your womb) and the umbilical cord (the umbilical cord is attached to the placenta) are sending oxygen and nutrients from the mother's blood through the umbilical cord to the baby. After a baby is born the cord is clamped and babies have to start breathing and support themselves. At the moment when a baby with congenital heart disease is born they will have their cord clamped immediately (this is called immediate cord clamping (ICC)). After ICC the clinical team will start to help a baby transition by carefully monitoring their oxygen saturation (give oxygen if needed), provide warmth, and dry and stimulate. Several animal studies have shown that clamping the cord right after birth might causes the baby to miss the benefits of receiving blood from the umbilical cord / placenta. Delayed Cord Clamping (DCC) is when the baby stays attached to the cord for a longer time. Studies show that DCC has many benefits especially for a newborn baby, such as higher iron storage, less need for blood transfusions, and improved circulation. This can be done while the baby is breathing on its own or while we help you baby breath (this is called resuscitation). This study aims to examine whether DCC while providing resuscitation in infants with CHD is helpful compared to immediate cord clamping. Prior to the birth of your baby, a sealed envelope will be opened and your baby will be randomly assigned to either the DCC with resuscitation group or the ICC group. 40 babies will be enrolled into this study, 20 in each group. In the DCC group, the umbilical cord will be clamped after 120 seconds during which time your baby will receive the care he/she requires by the NICU team. In the ICC group, the umbilical cord will be clamped immediately and he/she will be brought over the resuscitation bed to be cared for by the same team.

NCT ID: NCT03678909 Recruiting - Clinical trials for Congenital Heart Disease

Cardiac Biomarkers in Patients With Single Ventricle Physiology

Start date: March 1, 2018
Phase:
Study type: Observational

All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule. These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

NCT ID: NCT03677232 Completed - Quality of Life Clinical Trials

The Living Experience of Hong Kong Chinese Adolescents With CHD.

Start date: August 11, 2017
Phase:
Study type: Observational [Patient Registry]

This study aims to explore the impacts of CHD and its limitations on adolescents and the living experience of adolescents living with CHD. Hong Kong Chinese adolescents with CHD are having reduced psychological well-being and quality of life than their healthy counterparts. Qualitative study is therefore needed to explore how CHD may impact on the adolescents' psychological well-being and quality of life.

NCT ID: NCT03667703 Not yet recruiting - Infection Clinical Trials

Stress Ulcer Prophylaxis Versus Placebo in Critically Ill Infants With Congenital Heart Disease

SUPPRESS-CHD
Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Infants with congenital heart disease often require an intervention during their first year of life. Infants are generally admitted to a cardiac intensive care unit and are routinely prescribed stress ulcer prophylaxis to decrease acid release from the stomach to prevent stress ulcer formation. However, these medicines may not be safe and could put infants at increased risk for hospital-acquired infections, necrotizing enterocolitis and alteration to the infant's microbiome. The investigators plan to assess the feasibility of conducting a prospective, blinded randomized control trial to determine the safety of withholding stress ulcer prophylaxis in critically ill infants with congenital heart disease. In addition, the investigators plan to examine the changes to the infant's microbiome through oral, gastric and stool samples and compare hospital-acquired infections.

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".

NCT ID: NCT03630796 Recruiting - Clinical trials for Congenital Heart Defects

Effect of Sevoflurane in Postoperative Troponin I Levels in Children Undergoing Congenital Heart Defects Surgery

Start date: August 20, 2018
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to compare myocardial injury of patients undergoing congenital cardiac defects repair surgery (RACHS Risk Score one, two or three) under total intravenous anesthesia compared to inhalation anesthesia with sevoflurane. The primary aim of the study is to evaluate the troponin I levels in patients following congenital heart surgery and elucidate if one of the two anesthetic techniques (TIVA x inhalation anesthesia) is more effective in reducing troponin I levels in the first 72h after surgery.. Sixty six are planned to be included in the study and the follow-up will take approximately 3 days for the primary outcome. As a secondary outcome evaluate the BNP, CPK and CKMB postoperative levels in the same period (72h), also ICU and hospital lengh of stay (LOS), duration of mechanical ventilation, inotropic/vasoactive drugs use and incidence of renal injury (according to pediatric RIFLE score).