NCT04666857

Family Centred Early Intervention of Infants With Congenital Heart Disease

Family Centred Early Intervention to Improve Motor Development of Infants With Severe Congenital Heart Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University Children's Hospital, Zurich · Academic / Other
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	early motor intervention	infants with CHD after open heart surgery will receive early intervention

Timeline

• Start date: 2021-05-31
• Primary completion: 2022-12-19
• Completion: 2023-02-20
• First posted: 2020-12-14
• Last updated: 2023-09-21

Locations

1 site across 1 country: Switzerland