Status:
COMPLETED
Family Centred Early Intervention of Infants With Congenital Heart Disease
Lead Sponsor:
University Children's Hospital, Zurich
Conditions:
Congenital Heart Disease in Children
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
In this study the investigators aim to test the feasibility for therapists and acceptability to parents of an early motor intervention for infants with congenital heart disease (CHD) after open heart ...
Detailed Description
In this feasibility pilot randomised study children will be randomly assigned to a control and an intervention group. Children of the control group will receive standard of care for infants with sever...
Eligibility Criteria
Inclusion
- Infants born with severe cyanotic and acyanotic congenital heart disease (e.g. tetralogy of Fallot, pulmonary atresia, transposition of the great arteries, atrial/ventricular septal defects, double outlet right ventricle, ...) who undergo open-heart surgery once before the first 3-6 months of their life
- Parents able to comprehend the patient information linguistically and cognitively
- Informed consent of parents as documented by signature
Exclusion
- Infants with hypoplastic left heart syndrome as they need to undergo several open-heart surgeries within the first period of their life.
- Infants with trisomy 21 and other syndromes like 22q11 microdeletion syndrome, CHARGE syndrome that are often associated with CHD. These infants often show additional cognitive impairments that might confound the effect of our intervention.
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04666857
Start Date
May 31 2021
End Date
February 20 2023
Last Update
September 21 2023
Active Locations (1)
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1
University Children's Hospital
Zurich, Switzerland, 8032