[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"congenital-heart-disease-in-children\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:congenital-heart-disease-in-children":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,73,105,131,157,183,213,245,270,296,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100639548","adaptive-digital-exercise-rehabilitation-for-children-after-chd-surgery-100639548",false,"NCT07574463","Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery","Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery","Inclusion Criteria:\n\n* Children aged 6 to 12 years\n* Diagnosed with congenital heart disease (CHD) and have undergone cardiac surgery\n* Clinically stable after transfer to the general ward, with stable circulatory, respiratory, musculoskeletal, and neurological status, and assessed by the clinician as suitable to begin active exercise rehabilitation\n* Able to understand and cooperate with basic exercise training requirements\n* Written informed consent provided by the child and the legally authorized guardian\n\nExclusion Criteria:\n\n* Absolute contraindications to exercise rehabilitation, including uncontrolled arrhythmia, acute heart failure, hemodynamic instability, severe aortic stenosis, acute myocarditis, or acute pericarditis\n* Severe comorbid conditions that could interfere with rehabilitation, including severe hepatic or renal dysfunction, malignancy, or acute infection\n* Musculoskeletal or neuromuscular disorders that would prevent participation in or completion of the rehabilitation training","ALL","6 Years","12 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate whether a Just-in-Time Adaptive Intervention (JITAI)-based digital exercise rehabilitation program can improve postoperative recovery in children after congenital heart disease (CHD) surgery. The study will examine whether this system can:\n\nImprove cardiopulmonary endurance, cardiac function, and muscle strength Increase rehabilitation adherence and enhance training experience while reducing exercise-related fear Researchers will compare children receiving the adaptive digital exercise rehabilitation program with those receiving standard postoperative rehabilitation to determine whether the digital program provides additional clinical and behavioral benefits.\n\nParticipants will:\n\nWear non-invasive monitoring devices to collect real-time physiological data Engage in daily structured exercise rehabilitation sessions guided by the digital system Receive adaptive adjustments in exercise intensity based on real-time physiological feedback Complete questionnaires on recovery, emotional status, and rehabilitation experience",[27,28],"Congenital Heart Disease (CHD)","Congenital Heart Disease in Children",[30],"Just-in-Time Adaptive Intervention","NOT_YET_RECRUITING","2026-05-05",{"date":34,"type":35},"2026-05-08","ACTUAL",{"date":37,"type":21},"2026-12-30",{"date":39,"type":21},"2029-02-28",{"name":41,"class":42},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":43},"100517257","remote-cardiac-rehab-for-adolescents-with-congenital-heart-disease-100517257","NCT06015191","Remote Cardiac Rehab for Adolescents With Congenital Heart Disease","Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease","Remote-CaRe","Inclusion Criteria:\n\n1. Age 12-19 years old\n2. Male or Female\n3. Diagnosed with one of three congenital heart diseases:\n\n   Univentricular heart with Fontan Palliation Tetralogy of Fallot with transannular patch Dextro-transposition of the great arteries with arterial switch operation\n4. Primary Cardiology clearance for exercise participation\n5. Internet access in their homes\n6. Available for in-home exercise between 4-7pm on at least 3 days of the Monday-Friday work week\n7. English Speaking\n8. Achieving maximal effort on a cardiopulmonary exercise test, defined as RER ≥1.1 and\u002For in the judgement of the supervising exercise physiologist, a maximal effort was achieved but exercise capacity is limited by musculoskeletal deconditioning.\n\nExclusion Criteria:\n\n1. Physically or developmentally unable to perform outcomes assessments or participate in moderate-to-vigorous intensity physical activity\n2. Participating in \\> 15 MET-hours per week (mean weekly average over the past 12-months) of organized athletic\u002Fexercise activity (not including school physical education class).\n3. Height less than 132cm\n4. Pregnancy or planned surgery or procedure (excluding outpatient, non-cardiac procedures) within the 12-week study period.\n5. Meeting at least 1 exercise test safety or screening criteria on most recent exercise test (pre-study) or baseline outcomes visit exercise test\n6. Presence of significant cardiac dysfunction that would impair safe participation in moderate-to-vigorous intensity exercise\n7. Significant changes baseline echocardiogram or most recent clinical echocardiogram (from past clinical echocardiogram) such as decrease in ventricular and\u002For valvar function, new obstruction, or any new structural abnormalities\n8. Uncontrolled or poorly controlled asthma\n9. Presence of implanted cardioverter-defibrillator\n10. Pacemaker with rate-responsive function initiated\n11. Reliance on ventricular assist device\n12. Prescribed milrinone medication\n13. Listed for heart transplantation\n14. Active engagement in hormone replacement for gender transition","19 Years",{"count":54,"type":21},74,[24],"The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.",[28],[59,60,61,62],"Exercise","Cardiac Rehabilitation","Physical Activity","Telehealth","RECRUITING","2026-04-28",{"date":66,"type":35},"2026-05-04",{"date":68,"type":35},"2023-08-31",{"date":70,"type":21},"2027-12",{"name":72,"class":42},"Children's Mercy Hospital Kansas City",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":43},"100365606","phase-4-continuous-vs-intermittent-ketorolac-for-pain-control-in-peds-cv-surgery-100365606","NCT04040452","Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery","Continuous Infusion Versus Intermittent Ketorolac for Postoperative Pain Control in Pediatric Cardiac Surgery Patients","CIVIK","Inclusion Criteria:\n\n1. All patients aged 3 months to 4 years 11months admitted post operatively to the CVICU during the time period in which the study will be ongoing\n2. Initiation of study medication within the first 12-24 hours post-operatively\n3. The cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive Ketorolac for pain control\n\nExclusion Criteria:\n\n1. Patients that have acute kidney injury, as defined by the letter \"I\" in the pRIFLE criteria.\n2. History of allergy or sensitivity reaction to ketorolac or any NSAID medications.\n3. Requiring mechanical circulatory support (ECMO) or continuous renal replacement therapy (CRRT) within the first 48 hours post-operatively\n4. Orthotopic heart transplantation\n5. Clinically significant bleeding\n6. Patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity","3 Months","59 Months",{"count":84,"type":21},166,[86],"PHASE4","The proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular ICU. We intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.",[28],[90,91,92,93,94,95],"pain control","cardiac surgery","pediatric","opioid","NSAID","congenital heart disease","2026-04-22",{"date":98,"type":35},"2026-04-27",{"date":100,"type":35},"2021-03-01",{"date":102,"type":21},"2026-12-01",{"name":104,"class":42},"Phoenix Children's Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":111,"enrollmentInfo":112,"targetDuration":114,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100408895","outcomes-and-health-care-resource-utilization-in-pediatric-congenital-heart-disease-patients-undergoing-non-cardiac-procedures-100408895","NCT04604418","Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures","Inclusion Criteria:\n\n1. Males or females ages birth to 21 years.\n2. Patients diagnosed with congenital heart disease\n3. Patients undergoing a noncardiac procedure (surgical or nonsurgical)\n\nExclusion Criteria:\n\n1. Patients with congenial heart disease undergoing a cardiac surgical procedure including pacemakers.\n2. Patients with congenital heart disease undergoing a catheterization(diagnostic or interventional) or an electrophysiology study","21 Years",{"count":113,"type":21},10000,"1 Month","OBSERVATIONAL","The incidence of moderate to severe congenital heart disease (CHD) in the United States is estimated to be 6 per 1000 live-born full term infants. Recent advances in pediatric cardiology, surgery and critical care have significantly improved the survival rates of patients with CHD leading to an increase in prevalence in both children and adults. Children with CHD significant enough to require cardiac surgery frequently also undergo non-cardiac surgical procedures. Analysis of the Pediatric Health Information System database between 2004 and 2012 demonstrated that 41% of children who had undergone surgery to correct CHD in the first year of life also underwent at least one non-cardiac surgery by age 5. With this increased demand for non-cardiac procedures, anesthesiologists, pediatricians and other healthcare providers will encounter patients with repaired or unrepaired CHD and other cardiac diseases in their practice.\n\nHowever, the information provided by national databases lack granularity and the information from single institutional data is limited.\n\nThis project aims to address this knowledge gap in quantifying the risk for cardiac patients coming for noncardiac procedures and identify the health care resource utilization and system to best care for this patient population. To conduct this study, we will create a multi-institutional collaboration between large and small centers to create a unique dataset spanning all the different variables that need to be considered in risk prediction for these patients including patient variables, hospital setting, and providers. The aggregate multiinstitutional data set may be used for benchmarking for national quality improvement efforts.",[28],[119,120],"Perioperative risk prediction","Adverse Postoperative Outcomes","2026-04-01",{"date":123,"type":35},"2026-04-07",{"date":125,"type":35},"2020-10-01",{"date":127,"type":21},"2026-12-31",{"name":129,"class":42},"Boston Children's Hospital",10,{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":43},"100624793","evaluation-of-preoperative-preparation-in-children-undergoing-cardiac-surgery-or-catheterization-100624793","NCT07414251","Evaluation of Preoperative Preparation in Children Undergoing Cardiac Surgery or Catheterization","Evaluation of the Preoperative Preparation for Pediatric Cardiac Surgery and Pediatric Cardiac Catheterization Procedures","GETREADY","Inclusion Criteria:\n\n* All children undergoing cardiac surgery or cardiac catheterization.\n\nExclusion Criteria:\n\n* Children who are already intubated or tracheotomized and sedated.\n* Children and families who, due to insufficient language skills and lack of interpreters, cannot be informed about the study and cannot consent, and\u002For cannot complete the questionnaires.\n* Emergency interventions.\n* Death of the child.","18 Years",{"count":141,"type":21},200,"Children undergoing cardiac surgery or cardiac catheterization often experience significant stress and anxiety during the preoperative period. A prospective, observational assessment of the preoperative\u002F preinterventional phase in 100 children undergoing cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité demonstrated a considerable proportion of pediatric patients present with clinically relevant levels of anxiety before these procedures. Several aspects of the preoperative workflow were identified as potentially modifiable to improve the preparation of children and their families.\n\nBased on these findings, changes in clinical practice were implemented. These measures aim to create a more supportive environment for children undergoing cardiac interventions or surgery.\n\nThe investigators now aim to re-evaluate the current preoperative preparation process for children undergoing cardiac surgery or cardiac catheterization at the Deutsches Herzzentrum der Charité and to assess its impact on preoperative stress and anxiety levels. Another 100 children will be enrolled for this follow-up assessment (100 children assessed at baseline in 2025, 100 children to be assessed in 2026, starting end of January 2026). Anxiety and stress and other patient reported outcome and experience measures as well as procedural and clinical data are assessed using validated questionnaires and CRFs prior to the procedure. The perspectives of parents or legal guardians and members of the clinical care team will also be considered to provide a comprehensive view of the preoperative experience.",[28],[145,95,146,147],"anxiety","PROMS","PREMS","2026-02-10",{"date":150,"type":35},"2026-02-17",{"date":152,"type":35},"2025-01-09",{"date":154,"type":21},"2026-06-15",{"name":156,"class":42},"Charite University, Berlin, Germany",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":139,"enrollmentInfo":164,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100595190","blood-based-assessment-of-sst2-taken-during-and-after-surgery-for-pediatric-patients-with-heart-defects-to-predict-heart-failure-100595190","NCT07029230","Blood Based Assessment of sST2, Taken During and After Surgery, for Pediatric Patients With Heart Defects to Predict Heart Failure.","Biomarker in Congenital Cardiac Surgery - sST2 Marker in Heart Failure in Congenital Heart Disease After Surgery Research and Translational Study","Inclusion Criteria:\n\n* Consented for cardiopulmonary bypass surgery for cardiac reason\n* Conversational skills in German (by child and\u002For representative) to be able to fully understand and sign a written consent in German language\n\nExclusion Criteria:\n\n* Know genetic life limiting conditions\n* Syndrome patients who are scheduled or highly likely to be operated on more than one organ\n* Body weight at time of surgery less than 2.5 kg\n* Being recruited and enrolled for an interventional study protocol",{"count":165,"type":21},225,"Patients younger than 18 scheduled for congenital heart surgery will be assessed during and post-operatively as well as at the first follow-up after 9-12 month for the novel biomarker sST2. We will assess the marker independently and in evaluation with other blood biomarkers to evaluate sings of heart failure. Compared to established biomarkers, sST2 promises thereby to be less variable to factors like age or acute kidney injury, rendering it potentially more reliable in the field of congenital cardiac surgery.",[168,28,169],"Congenital Heart Surgery","Fontan Physiology",[171,172,173],"biomarker","sst2","congenital heart surgery","2025-11-14",{"date":176,"type":35},"2025-11-17",{"date":178,"type":35},"2025-09-10",{"date":180,"type":21},"2029-01-31",{"name":182,"class":42},"Martin Schweiger",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":212},"100549227","feasibility-and-efficiency-of-screening-for-neurodevelopmental-disorders-by-an-advanced-practice-nurse-in-children-with-congenital-heart-disease-100549227","NCT06431269","Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease","NEURODEV-IPA","Inclusion Criteria:\n\n* Congenital heart disease with stable status defined by last operation \\>3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion\n* Cardiac surgery and\u002For catheter-based cardiac intervention(s) during the first year of life,\n* Patient aged 1 to 5 years.\n* No previous medical diagnosis of NDD\n* Parental or legal guardian's consent.\n* Social security affiliation (for France only)\n\nExclusion Criteria:\n\n* Patients with a genetic or poly-malformative syndrome with known neurological impairment.\n* Neurodevelopmental disorder already known\u002Ftreated\n* Neurodevelopmental status evaluation within the last 6 months.","1 Year","5 Years",{"count":193,"type":21},270,[24],"Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease",[28,197],"Neurodevelopmental Disorders",[95,199,200,201,202],"neurodevelopmental screening","advanced practice nurse","organization of care","neuropsychological assessment","2025-09-24",{"date":205,"type":35},"2025-09-25",{"date":207,"type":35},"2024-05-31",{"date":209,"type":21},"2028-06",{"name":211,"class":42},"University Hospital, Montpellier",3,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":219,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":227,"conditions":228,"keywords":231,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":244},"100498217","phase-2-fetal-cerebrovascular-autoregulation-in-congenital-heart-disease-and-association-with-neonatal-neurobehavior-100498217","NCT05767385","Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior","Inclusion Criteria:\n\n* Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth.\n\nExclusion Criteria:\n\n* Known fetal chromosomal or genetic abnormalities\n* Multiple gestation pregnancy\n* Fetal extra-cardiac anomalies","FEMALE","0 Years","52 Years",{"count":223,"type":21},150,[225,226],"PHASE2","PHASE3","Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design.\n\nPregnant women will be approached during one of their fetal cardiology clinic visits.",[28,229,197,230],"Hypoxia","Complex Congenital Heart Disease",[232,233,234],"Congenital Heart Disease","Maternal Fetal","Neonatal Neurodevelopment","2025-06-18",{"date":237,"type":35},"2025-06-25",{"date":239,"type":35},"2021-12-17",{"date":241,"type":21},"2025-12",{"name":243,"class":42},"University of Utah",5,{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":4,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":16,"minAge":252,"maxAge":139,"enrollmentInfo":253,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":4},"100374635","erector-spinae-plane-block-in-congenital-heart-disease-patients-100374635","NCT04158024","Erector Spinae Plane Block in Congenital Heart Disease Patients","The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients","Inclusion Criteria:\n\n* Neonates of at least 32 weeks of gestation, infants and children admitted to The Lucile Packard Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.\n* Admitting diagnosis of cyanotic or non-cyanotic heart disease\n\nExclusion Criteria:\n\n* Neonates less than 32 weeks of gestational age\n* Any documented central nervous system malformations.\n* Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support","32 Weeks",{"count":223,"type":21},[24],"Pediatric cardiac patients undergoing surgical anesthesia are at an increased risk of poor neurologic outcome (20-50%). Unattenuated anesthetic exposure and pain contributes to physiologic perturbations that may increase neurologic morbidity. Because of the often-large exposure to anesthetic agents in these cardiac children, at such a young age and the potential modifying anesthetic practice that could lead to improved neurodevelopmental outcomes and surgical recovery is paramount. Regional anesthesia such as thoracic epidurals provide effective analgesia and reduced intraoperative anesthetic needed but carry devastating sequelae neurological risks of epidural hematomas after anticoagulation during cardiopulmonary bypass (CPB). Recently, a newly described erector spinae plane block (ESPB) is superficial to neuraxial or vascular structures, providing opportunity to be placed with less risk for surgery requiring CPB. This block has been described as effective regional anesthesia for adult cardiac surgery.",[28,257],"Neurologic Complication",[259,260],"Erector Spinae Plane Blockade","Pediatric Congenital Heart Disease","2025-04-30",{"date":263,"type":35},"2025-05-01",{"date":265,"type":21},"2025-11",{"date":267,"type":21},"2026-11",{"name":269,"class":42},"Stanford University",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":277,"maxAge":139,"enrollmentInfo":278,"targetDuration":4,"studyType":22,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":43},"100586210","community-based-remote-cardiac-rehabilitation-program-for-pediatric-patients-with-complex-congenital-heart-disease-100586210","NCT06912412","Community-Based Remote Cardiac Rehabilitation Program for Pediatric Patients With Complex Congenital Heart Disease","Development and Validation of a Community-Based Remote Cardiac Rehabilitation Program for Improving Cardiopulmonary Function and Quality of Life in Pediatric Patients With Complex Congenital Heart Disease","Inclusion Criteria:\n\n1. Aged between 8 and 18 years\n2. Diagnosed with complex congenital heart disease (Complex CHD) and have undergone surgery\n3. At least 3 months post-cardiac surgery with a stable hemodynamic status\n4. Capable of using remote programs (e.g., mobile apps, video-conferencing platforms) at home, with technical support from a caregiver\n5. Either the participant or their caregiver agrees to study participation and has signed the informed consent form\n\nExclusion Criteria:\n\n1. Patients with uncontrolled arrhythmias, acute heart failure, myocarditis, pericarditis, or other ongoing cardiovascular conditions.\n2. Patients who are unable to exercise independently due to neurological or musculoskeletal disorders.\n3. Patients who cannot understand or carry out remote rehabilitation program instructions due to cognitive impairment.\n4. Patients showing clinically significant levels of depression or anxiety on the CDI-2 or RCMAS.\n5. Patients who cannot cooperate with required study assessments (e.g., CPET, ECG, 6MWT).","8 Years",{"count":130,"type":21},[24],"This study is to develop a 12-week community-based remote cardiac rehabilitation program for pediatric patients with complex congenital heart disease and to assess its validity and safety.\n\nFor these children, a multidisciplinary approach including pediatric rehabilitation medicine, pediatric thoracic surgery, pediatrics, pediatric psychiatry, sports science, and nutrition is essential, but such comprehensive services are rarely available in Korea. As a result, pediatric cardiac rehabilitation at the community level is nearly nonexistent. Recent long-term retrospective cohort studies suggest that maintaining regular physical activity and aerobic capacity from early childhood significantly reduces future cardiovascular complications, emphasizing the importance of early pediatric cardiac rehabilitation. However, participation in existing programs is low due to limited accessibility.\n\nThe investigators hypothesize that a community-based remote cardiac rehabilitation program for these patients is both valid and safe. Participants will be children aged 8-18 years diagnosed with complex congenital heart disease , at least 3 months post-surgery, and stable cardiovascular status.\n\nInterventions include supervised and self-directed cardiac rehabilitation exercises. Monitoring (heart rate, SpO2, ECG) will be performed in real-time, with non-real-time data collection of physical activity using smartwatches. The intervention lasts 12 weeks with a 12-week follow-up.\n\nValidity measures include baseline evaluation, adherence, dropout rate, participant and parent satisfaction, and changes in cardiopulmonary exercise capacity, physical activity, body composition, fitness (6-minute walk, strength, flexibility, respiratory muscle strength), and questionnaires (physical activity, quality of life, exercise satisfaction, depression, psychological state).\n\nSafety will be assessed by monitoring adverse events, vital signs, fatigue (Borg scale), and pain before and after exercise.",[27,230,28],[283,284,285,286],"Complex congenital heart disease","remote cardiac rehabilitation","cardiac rehabilitation","children cardiac rehabilitation","2025-03-30",{"date":289,"type":35},"2025-04-04",{"date":291,"type":21},"2025-05-31",{"date":293,"type":21},"2029-12-31",{"name":295,"class":42},"Seoul National University Hospital",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":114,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":329},"100379195","phase-3-cerebrum-and-cardiac-protection-with-allopurinol-in-neonates-with-critical-congenital-heart-disease-requiring-cardiac-surgery-with-cardiopulmonary-bypass-100379195","NCT04217421","Cerebrum and Cardiac Protection With Allopurinol in Neonates With Critical Congenital Heart Disease Requiring Cardiac Surgery With Cardiopulmonary Bypass","CRUCIAL","Inclusion Criteria:\n\n* Neonates with a prenatally or postnatally confirmed diagnosis of CCHD requiring (anticipated) cardiac surgery with CPB within the first 4 weeks of life.\n* Informed consent provided by both parents.\n\nExclusion Criteria:\n\n* Inability to enroll the patient before the start of delivery in case of prenatal diagnosis, or 24 hours before surgery in case of postnatal diagnosis.\n* Doubt whether the aortic arch anomaly before birth requires cardiac surgery with CPB in the neonatal period.\n* Gestational age below 36 weeks and\u002For birth weight less than 2000 gram.\n* Surgery not requiring cardiopulmonary bypass.\n* Decision for \"comfort care only\".",{"count":304,"type":21},236,[226],"Neurodevelopmental impairment due to delayed brain development and brain injury is a fundamental problem in children with critical congenital heart disease (CCHD). Significant longterm motor-, cognitive-, and behavioral problems are the result of early postnatally and perioperatively induced brain injury. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of toxic free oxygen radicals, thereby limiting hypoxia-reperfusion damage. Both animal and neonatal studies suggest that administration of allopurinol reduces hypoxic-ischemic brain injury, is cardioprotective, and safe. This study aims to evaluate the efficacy and safety of allopurinol administered early postnatally and perioperatively in children with a CCHD requiring cardiac surgery with cardiopulmonary bypass.",[28,308],"Neuroprotection",[232,308,310,311,312,313,314,315,316,317,318,319],"Allopurinol","Brain injury","Cardiopulmonary bypass","Brain function","Brain oxygenation","Cardiac function","Neurodevelopmental outcome","Cardiac surgery","Hypoxic-ischemic brain injury","Neonates","2024-05-13",{"date":322,"type":35},"2024-05-16",{"date":324,"type":35},"2020-02-14",{"date":326,"type":21},"2028-12-31",{"name":328,"class":42},"dr. M.J.N.L. Benders",4,{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100544808","cardiac-simulator-for-surgical-planning-100544808","NCT06373705","Cardiac Simulator for Surgical Planning","Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients","Inclusion Criteria:\n\n* The inclusion criteria are pediatric patients ages 0-17 with a congenital heart disease (CHD) diagnosis of 1) congenitally corrected transposition of the great arteries (cc-TGA) with ventricular septal defect (VSD), 2) double outlet right ventricle (DORV) with remote VSD, or 3) other single ventricle conditions.\n\nExclusion Criteria:\n\n* Adult patients with CHD.","17 Years",{"count":339,"type":21},275,[24],"The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:\n\nTo provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.\n\nTo aid surgeons in envisioning different surgical approaches for each individual patient.\n\nTo bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.\n\nParticipants will:\n\nConsent to being randomized with a 50% chance of receiving standard of care \"on the fly\" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.\n\nReceive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.",[28],"2024-04-17",{"date":345,"type":35},"2024-04-22",{"date":347,"type":21},"2026-04",{"date":349,"type":21},"2029-04",{"name":269,"class":42}]