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The implementation of EMI-Heart, a family-tailored early motor intervention in infants with complex congenital heart
Elena Mitteregger1,2,3, Tineke Dirks4, Manuela Theiler5
1Child Development Center, University Children's Hospital Zurich, Steinwiesstrasse 75, Zurich, CH-8032, Switzerland. elena.mitteregger@kispi.uzh.ch.
Insights
This study found that the early motor intervention (EMI-Heart) is feasible for infants with congenital heart disease (CHD) after surgery. While motor outcomes did not differ, the intervention improved family well-being, with high parent and therapist acceptance.
Area of Science:
- Pediatric Cardiology
- Developmental Pediatrics
- Rehabilitation Therapy
Background:
- Infants with congenital heart disease (CHD) undergoing open-heart surgery face risks of developmental delays, particularly motor impairment.
- Parental stress is a significant concern for families of children with CHD, exacerbated by a lack of early interventions.
- A family-tailored early motor intervention (EMI-Heart) was developed to address motor development and family well-being in infants with CHD.
Purpose of the Study:
- To evaluate the feasibility and acceptability of the EMI-Heart intervention in infants with CHD.
- To assess the intervention's impact on infant motor outcomes and family well-being.
- To establish a foundation for a larger clinical trial.
Main Methods:
- A single-centre feasibility randomized controlled trial (RCT) involving infants with CHD post-surgery.
- Infants were randomized to either the EMI-Heart intervention group or a control group (standard care).
- The EMI-Heart intervention consisted of nine 3-month sessions delivered at home, in-hospital, and online by a pediatric physiotherapist.
Main Results:
- The study achieved a 59% recruitment rate, with 100% participant completion.
- The EMI-Heart intervention demonstrated high acceptability among parents and the pediatric physiotherapist.
- No significant differences in motor outcomes were observed between groups, but the intervention group showed improved family well-being scores.
Conclusions:
- The EMI-Heart intervention is feasible and highly acceptable for infants with CHD after open-heart surgery.
- Online delivery of therapy sessions presents a viable alternative to traditional home and hospital visits.
- This feasibility study supports the need for a full-scale trial to further investigate EMI-Heart's efficacy.
Background:
Children with congenital heart disease (CHD) who undergo open-heart surgery are at risk of developmental impairment, including motor delay, which contributes to parental concerns. Additionally, parents experience prolonged stress associated with their child's disease. There is a lack of early motor interventions in infants with CHD accounting for parental burdens. We developed a family-tailored early motor intervention (EMI-Heart), aiming to promote motor development in infants with CHD and family well-being. The primary aim was to evaluate the feasibility of the study design and the intervention. The secondary aim was to evaluate differences between the intervention and the control group in motor outcomes and family well-being at baseline (3-5 months), post-treatment (6-8 months), and at follow-up (12 months).
Method:
In this single-centre feasibility randomized control trial (RCT), infants with CHD after open-heart surgery without genetic or major neurological comorbidities were randomly allocated to EMI-Heart or the control group (standard of care). EMI-Heart's key elements promote postural functional activities and encourage parental sensitivity to infants' motor and behaviour cues. Infants assigned to EMI-Heart received nine sessions of early motor intervention at home, in the hospital, and online for a duration of 3 months by a paediatric physiotherapist. We performed descriptive statistics for feasibility and secondary outcomes.
Results:
The recruitment rate was 59% (10/17), all participating families completed the study (10/10), and the intervention duration was 3.9 months (± 0.54), including nine intervention sessions per family. Median acceptability to parents was 3.9 (1 = not agree-4 = totally agree, Likert scale). The paediatric physiotherapist considered the intervention as feasible. The comparison of motor outcomes did not show differences between groups. However, we detected improved reliable change scores in family well-being outcomes for families of the intervention group compared to the controls.
Conclusions:
Our research indicates that EMI-Heart is a feasible intervention for infants with CHD after open-heart surgery. The intervention was highly acceptable both to parents and to the paediatric physiotherapist. Online treatment sessions offer a valuable alternative to home and hospital visits. This feasibility RCT provides a foundation for a future full trial.
Trial Registration:
ClinicalTrials.gov, NCTT04666857. Registered 23.11.2020.
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