Clinical trial NCT04666857: Family Centred Early Intervention of Infants With Congenital Heart Disease
Official title: Family Centred Early Intervention to Improve Motor Development of Infants With Severe Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease in Children
Keywords: congenital heart diseases
open heart surgery
motor development
early intervention
family centred
physiotherapy
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 10
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective monocentric single-blinded, two-arm feasibility randomised controlled interventional pilot trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Dropout rate
timeFrame: "3 up to 6 months of age" (baseline) and at "12 months of age"
Secondary outcomes:
Other outcomes:
measure: Hammersmith Infant Neurological Examination
timeFrame: "3 up to 6 months of age" (baseline) and at "12 months of age"
measure: General Movements
timeFrame: "3 up to 6 months of age" (baseline)
measure: Infant Motor Profile
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention), at "12 months of age"
measure: Alberta Infant Motor Scale Change in being assessed at different time points at baseline, at the end of the intervention after three months and at follow up
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
measure: Bayley Scale for Infant and Toddlers Development
timeFrame: "around 12 months of age"
measure: Parental Stress Index
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
measure: Brief Symptom Inventory 18
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
measure: Parental Overprotection Measure
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
measure: Family Empowerment Scale
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
measure: Quality of life form Short Form 36
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
measure: Pediatric Quality of Life Inventory
timeFrame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital
Study officials:
affiliation: University Children's Hospital, Zurich
name: Bea Latal, Dr. med.
role: STUDY_DIRECTOR
References: