Congenital Heart Disease Clinical Trial
Official title:
Creative Music Therapy in Newborns With Congenital Heart Disease: A Randomized Clinical Trial
In the context of a clinical trial, the investigators will evaluate if parent-infant interaction can be improved by a family integrated, individualised, interactive resource- and needs-oriented music therapy approach in the dyads of infants with congenital heart disease and their parents. This intervention will be compared with the standard of care. Infants allocated to the control group will receive standard care during admission. Standard care includes involvement of a multi-professional team consisting of medical and nursing team, psychologists/psychiatrists, social workers, breastfeeding counsellor, speech therapist, nutritional counsellor and physiotherapists.
Open label single-centre randomised controlled interventional trial. All infants with congenital heart disease (CHD) and age <28 days admitted to the neonatal and paediatric intensive care unit at the University Children's Hospital in Zurich are eligible. Infants will be allocated 1:1 to creative music therapy (CMT) and standard care using block randomization with stratification by socio-economic score (SES, <8 vs >8) and risk of CHD according to the Risk Stratification for Congenital Heart Surgery (RACHS-2). CMT will be conducted 3x/week with a minimum of ten sessions. The primary outcome is mother-infant interaction at age 6 months assessed using a video of a feeding interaction at home, coded in a blinded manner with the Parent-Child Early Relational Assessment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT04992793 -
Paediatric Brain Injury Following Cardiac Interventions
|
||
| Recruiting |
NCT05213598 -
Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
|
||
| Completed |
NCT04136379 -
Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
|
||
| Completed |
NCT04814888 -
3D Airway Model for Pediatric Patients
|
||
| Recruiting |
NCT04920643 -
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
|
N/A | |
| Completed |
NCT05934578 -
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
|
N/A | |
| Recruiting |
NCT06041685 -
Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia
|
N/A | |
| Recruiting |
NCT05902013 -
Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation
|
N/A | |
| Not yet recruiting |
NCT05687292 -
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
|
||
| Not yet recruiting |
NCT05524324 -
Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT
|
N/A | |
| Completed |
NCT02746029 -
Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
|
||
| Completed |
NCT03119090 -
Fontan Imaging Biomarkers (FIB) Study
|
||
| Completed |
NCT02537392 -
Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease
|
N/A | |
| Recruiting |
NCT02258724 -
Swiss National Registry of Grown up Congenital Heart Disease Patients
|
||
| Terminated |
NCT02046135 -
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
|
Phase 2 | |
| Completed |
NCT01966237 -
Milrinone Pharmacokinetics and Acute Kidney Injury
|
||
| Recruiting |
NCT01184404 -
Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery
|
N/A | |
| Completed |
NCT01548950 -
Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension
|
N/A | |
| Completed |
NCT01178710 -
Effect of Simvastatin on Cardiac Function
|
N/A |