Family Centred Early Intervention of Infants With Congenital Heart Disease

NCT ID: NCT04666857

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2023-02-20

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 surgery. This intervention will be compared to the standard care of treatment that is recommended for infants with congenital heart disease at the University Children Hospital Zurich.

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 severe CHD: cardiac surveillance, counselling and screening at the University Children's Hospital Zurich and standardised developmental checkups by their paediatrician. Physiotherapy is normally not comprised in standard of care, but some infants may receive physiotherapy, if they present with obvious signs of motor developmental delay, detected by the paediatrician later on in their life. Once enrolled in this study, an infant of the control group will not receive early motor intervention as an infant enrolled in the intervention group.

Infants randomly assigned to the intervention group will receive early motor intervention, which will be based on the results of our qualitative study. It will comprise supporting parents by a paediatric physiotherapist. Parents will be guided on how to best stimulate their infant's development during daily activities. Parents will be actively involved in the intervention with the aim to challenge their infant at the limit of its postural capacity and thus help the infant to optimize its motor repertoire. The intervention will start after baseline with infants aged 3-6 months and end after three months with infants aged 6-9 months.

The intervention will start at home, then alternating at the Children's Hospital and at home. Telephone or video counselling will be provided to support parents if needed. The order may change according to the needs of the family when necessary and adjusted to best fit the daily routine the family.

Conditions

Congenital Heart Disease in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard care

Control subject will receive standard care of treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

intervention group will receive early intervention

Group Type: EXPERIMENTAL

early motor intervention

Intervention Type: OTHER

infants with CHD after open heart surgery will receive early intervention

Interventions

early motor intervention

infants with CHD after open heart surgery will receive early intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Children's Hospital, Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bea Latal, Dr. med.

Role: STUDY_DIRECTOR

University Children's Hospital, Zurich

Locations

University Children's Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

EMI

Identifier Type: -

Identifier Source: org_study_id