Mitteregger Elena, Dirks Tineke, Theiler Manuela, Kretschmar Oliver, Latal Beatrice
Child Development Center, University Children's Hospital Zurich, Steinwiesstrasse 75, Zurich, CH-8032, Switzerland.
Children's Research Center, University Children's Hospital Zurich, Zurich, Switzerland.
Pilot Feasibility Stud. 2024 Aug 2;10(1):105. doi: 10.1186/s40814-024-01532-1.
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).
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.
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.
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.
ClinicalTrials.gov, NCTT04666857. Registered 23.11.2020.
接受心脏直视手术的先天性心脏病（CHD）患儿有发育受损的风险，包括运动迟缓，这引起了家长的担忧。此外，家长因孩子的疾病而长期承受压力。目前缺乏针对CHD婴儿的早期运动干预措施，这增加了家长的负担。我们开发了一种针对家庭的早期运动干预方案（EMI-Heart），旨在促进CHD婴儿的运动发育和家庭幸福。主要目的是评估研究设计和干预措施的可行性。次要目的是评估干预组和对照组在基线（3-5个月）、治疗后（6-8个月）和随访（12个月）时运动结果和家庭幸福方面的差异。
在这项单中心可行性随机对照试验（RCT）中，将心脏直视手术后无遗传或重大神经合并症的CHD婴儿随机分配到EMI-Heart组或对照组（标准护理组）。EMI-Heart的关键要素是促进姿势功能活动，并鼓励家长对婴儿的运动和行为线索保持敏感。分配到EMI-Heart组的婴儿由儿科物理治疗师在家中、医院和线上接受为期3个月的九次早期运动干预。我们对可行性和次要结果进行了描述性统计。
招募率为59%（10/17），所有参与家庭均完成了研究（10/10），干预持续时间为3.9个月（±0.54），每个家庭包括九次干预课程。家长的中位可接受性为3.9（1=不同意-4=完全同意，李克特量表）。儿科物理治疗师认为该干预措施可行。运动结果的比较未显示组间差异。然而，与对照组相比，我们发现干预组家庭的家庭幸福可靠变化得分有所改善。
我们的研究表明，EMI-Heart对心脏直视手术后的CHD婴儿是一种可行的干预措施。该干预措施对家长和儿科物理治疗师都非常可接受。线上治疗课程为家访和医院就诊提供了有价值的替代方案。这项可行性RCT为未来的全面试验奠定了基础。
ClinicalTrials.gov，NCTT04666857。于2020年11月23日注册。
