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Completed

NCT Number: NCT04666857

Family Centred Early Intervention of Infants With Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease in Children Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

2 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital

Zurich, 8032, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

early motor intervention

Other

infants with CHD after open heart surgery will receive early intervention

Primary outcomes

  1. Dropout rate

    Time frame: "3 up to 6 months of age" (baseline) and at "12 months of age"

    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.

Other outcomes

  1. Hammersmith Infant Neurological Examination

    Time frame: "3 up to 6 months of age" (baseline) and at "12 months of age"

    The Hammersmith Infant Neurological Examination assesses different aspects of neurological function.

    the higher the scores the better, the range depends on the child's abilities metric: ordinal

  2. General Movements

    Time frame: "3 up to 6 months of age" (baseline)

    The General Movement assessment is a video-based, non-invasive way to identify neurological deviations that may lead to neurodevelopmental disorders later in life.

    The more variables the motor output of infants, the better infants' neuromotor development will be.

    metric: categorial

  3. Infant Motor Profile

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention), at "12 months of age"

    The Infant Motor Profile is a standardised and qualitative method to assess motor behaviour in infants, a 15 minutes, video-based assessment tool, consists of 5 domains: motor variation, adaptability, symmetry, fluency and performance.

    The higher the score, the better - the range depends on the child's abilities and is age dependent metric: ordinal

  4. 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

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Alberta Infant Motor Scale is an observational measure of infants' gross motor development from birth until 18 months consisting of 58 items, measuring infants' performance; The higher the score, the better, the range depends on the child's abilities and is age dependent

    metric: ordinal

  5. Bayley Scale for Infant and Toddlers Development

    Time frame: "around 12 months of age"

    Bayley Scale for Infant and Toddlers Development is an internationally used and validated battery to assesses key domains of cognition, language, socio-emotional, motor and adaptive behaviour by standardized observation and rating of the play behaviour of children the higher the scores the better, the range depends on the child's abilities and is age dependent metric: ordinal

  6. Parental Stress Index

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Parental Stress Index investigates parental stress of children with all different kind of diagnoses, consists of 5 subscales assessing areas where parental strain is high; the Parental Stress Index consists of 48 items the lower, the score the better

    metric: ordinal

  7. Brief Symptom Inventory 18

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Brief Symptom Inventory 18 contains a three six-item scales somatization, depression, and anxiety as well as the Global Severity Index the lower, the score the better

    metric: ordinal

  8. Parental Overprotection Measure

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Parental Overprotection Measure assesses parenting behaviours that restrict a child's exposure to situations containing perceived threat or harm.

    the higher the scores the more parents protect their children metric: ordinal

  9. Family Empowerment Scale

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Family Empowerment Scale measures empowerment of families. It consists of three subscales, family, service system and community/political. We use the subscale family to gather relevant information as a result of an intervention.

    the higher the scores the more the family feels empowered metric: ordinal

  10. Quality of life form Short Form 36

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Quality of life form Short Form 36 is a widely used questionnaire assessing self-reported health related quality of life the lower the score the better

    metric: ordinal

  11. Pediatric Quality of Life Inventory

    Time frame: "3 up to 6 months of age" (baseline), "6 up to 9 months of age" (end of intervention) and at "12 months of age"

    The Pediatric Quality of Life Inventory measures quality of life of infants aged 1- 24 months.

    the higher the scores the more the quality of life is affected. metric: ordinal

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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