Congenital Heart Disease in Children Clinical Trial
Official title:
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.
In neonates with ductal-dependent blood flow there remains valid uncertainty regarding the comparative benefits of ductal artery stent (DAS) with the traditional systemic-to-pulmonary artery shunt (SPS) palliation due to the lack of previous multicenter studies. COMPASS is a prospective multicenter randomized interventional trial where participants will be randomized to receive either an SPS or DAS to compare rates of a composite major morbidity/mortality endpoint in the first year of life. The study objectives are to perform an intention-to-treat analysis of participants' outcomes, and to describe the failure rate for neonatal candidates for DAS and the impact of this failure on the post-SPS course. Participants will be followed through the first year of life. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05975658 -
WIReD: Wireless Interstage Remote Device Study
|
||
| Completed |
NCT05546983 -
How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
|
||
| Completed |
NCT03229538 -
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
|
Phase 3 | |
| Completed |
NCT05579964 -
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05128084 -
Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
|
||
| Recruiting |
NCT04604418 -
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
|
||
| Completed |
NCT05778240 -
Adherence to Palivizumab Prophylaxis
|
N/A | |
| Completed |
NCT04666857 -
Family Centred Early Intervention of Infants With Congenital Heart Disease
|
N/A | |
| Terminated |
NCT03136900 -
Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.
|
N/A | |
| Recruiting |
NCT05910320 -
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
|
N/A | |
| Not yet recruiting |
NCT05778175 -
Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
|
||
| Completed |
NCT05284500 -
Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery
|
||
| Completed |
NCT04295239 -
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
|
N/A | |
| Completed |
NCT05142046 -
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
|
||
| Recruiting |
NCT04040452 -
Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
|
Phase 4 | |
| Not yet recruiting |
NCT06431269 -
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
|
N/A | |
| Recruiting |
NCT04315610 -
Personalized Mobile App for Parents of Infants With Cardiac Disease
|
N/A | |
| Completed |
NCT04018079 -
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
|
||
| Recruiting |
NCT05496803 -
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
|
N/A | |
| Recruiting |
NCT05826769 -
To Assess the Efficacy of Early Administration of Energy Enriched and Protein Enriched Formula in Post Cardiac Repair Infants: a Randomized Controlled Trial, Comparative Study
|
N/A |