Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 14
- 主要终点
- Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
研究概览
简要总结
The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD) repair and children from the same clinical sites with DS without major congenital heart disease (CHD) requiring previous or planned CHD surgery.
详细描述
We are conducting a multicenter cohort study, ancillary to the Pediatric Heart Network (PHN) Residual Lesion Score (RLS) study, to investigate determinants of ND and behavioral outcomes in children with DS, focusing on the role of CHD surgery. We are including children with DS who had CAVSD repair, as this group comprises 91% of all children with DS in the RLS Study, with similar underlying congenital cardiac defect and surgical repair complexity, allowing our children with DS and CHD to be a homogeneous group. Moreover, one in five individuals with DS is born with an AVSD, a 2000 times higher incidence than in those with normal chromosomes. In addition to recruiting children with DS who had CAVSD repair, we will recruit similarly-aged children with DS who do not have documented major CHD (i.e., CHD requiring previous or planned CHD surgery) to come into the same PHN site for a single study visit consisting of detailed phenotyping by completion of a Health & Developmental History Intake form, ND and behavioral assessments, and optional collection and storage of saliva specimens in the PHN Biorepository. By building our sample from RLS Study participants and recruiting additional children who had infant CAVSD repair and meet study eligibility criteria, as well as a comparison group from the same PHN sites, we are leveraging rich prospective data in a group of DS children with CAVSD repair from a nationally representative sample, and the expertise of the PHN and Boston Children's Hospital (BCH).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Months 至 155 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Down Syndrome CAVSD Repair Group:
- •Trisomy 21
- •Male or Female, ages 5 years through 12 years
- •Had CAVSD repair within the first year of life
- •Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
- •Child able to speak and understand English
- •Down Syndrome Comparison Group
- •Trisomy 21
- •Male or Female, age 5 years through 12 years
- •No major CHD, defined as CHD requiring previous or planned CHD surgery
- •Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
- •Child able to speak and understand English
排除标准
- •Both Groups
- •Mosaic DS
- •Down Syndrome CAVSD Repair Group only - Did not have CAVSD repair in the first year of life
- •Down Syndrome Comparison Group only
- •Major CHD requiring previous or planned CHD surgery - i.e., CHD surgery occurring (a) in the period between birth and time of recruitment into the CHILD-DS Study, or (b) planned for a future date.
结局指标
主要结局
Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
时间窗: 1 day
Adaptive composite scores from the Vineland Adaptive Behavior Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Social Communication compared between the children with DS and CAVSD repair and the children with DS without major CHD.
时间窗: 1 day
Using the Social Communication Questionnaire, social communication, social interactions, play and behavior will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Language abilities compared between the children with DS and CAVSD repair and the children with DS without major CHD.
时间窗: 1 day
Using the Peabody Picture Vocabulary Test, Expressive Vocabulary Test, and Leiter International Performance Scale total language, auditory comprehension, and expressive communication will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
时间窗: 1 day
Verbal and non-verbal ratio intelligent quotients (IQs) derived from the Stanford Binet Intelligence Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Emotional outcomes compared between the children with DS and CAVSD repair and the children with DS without major CHD.
时间窗: 1 day
Using the Repetitive Behavior Scale and Aberrant Behavior Checklist , behavioral and emotional problems will be compared will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
次要结局
- Sociodemographic factors as predictors of neurodevelopment and behavior(1 day)
- Comorbidities as predictors of neurodevelopment and behavior(1 day)