Family Centred Early Intervention of Infants With Congenital Heart Disease

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Congenital Heart Disease in Children

Intervention / Treatment
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* Other: early motor intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective monocentric single-blinded, two-arm feasibility randomised controlled interventional pilot trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>Control subject will receive standard care of treatment | |
| Experimental: intervention group<br>intervention group will receive early intervention | Other: early motor intervention<br>* infants with CHD after open heart surgery will receive early intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout rate | The primary outcome will test the procedure for its acceptability, estimation the likely rates of recruitment and retention of subjects and the calculation of appropriate sample size. Further objectives are the usefulness of the outcome assessment measures. | 3 up to 6 months of age (baseline) and at 12 months of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart diseases, open heart surgery, motor development, early intervention, family centred, physiotherapy