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临床试验/NCT04152330
NCT04152330已完成不适用

Proposal for Parental Guidance and Early Stimulation in Children With Congenital Heart Disease: Randomized Trial

Instituto de Cardiologia do Rio Grande do Sul2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Difference between groups

研究概览

简要总结

Problem: With the increased survival rate of children with congenital heart disease, other health problems, in addition to the clinic, have emerged, such as the risks of developmental delay to which these children are exposed. There is a need for low-cost intervention studies that seek to minimize these risks.

Objective: To evaluate the effect of an early stimulation program using parents as vectors of intervention, on the neurodevelopment of children with CHD Methodology: Randomized clinical trial, conducted with 44 dyads of parents-babies with CH considered as medium and high risk for developmental delays according to the guidelines of the American Heart Association (2012). The study will consist of two groups G1 (Intervention) and G2 (controls). G1 parents will receive guidance for 6 weeks of stimulation activities and will be instructed to keep an online execution diary, direct with the researcher through videos, and messages via cell phone. G2 parents will receive the standard guidelines currently used in pediatric cardiology clinics. Children from both groups will be assessed at the beginning and end of the 6 weeks by the Bayley Baby and Toddler Development Scales (3rd Edition). A questionnaire on the applicability of the protocol will be administered to the parents of the intervention group Expected results: Better neuropsychomotor performance in children after applying the early stimulation protocol.

Perspectives: Create a body of information that can serve as a basis for the formulation of policies for intervention and surveillance of the development of this population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of congenital heart disease up to 3 months old.
  • Stable clinical condition (with medical clearance to receive the intervention), For parents
  • Parents are literate
  • Acceptance of the Responsible to participate in the research.
  • Have a mobile device capable of sending and receiving messages and videos.

排除标准

  • Suspected or diagnosed genetic syndrome;
  • Musculoskeletal or neurological malformation associated
  • inability to establish a primary caregiver as in the case of baby under state supervision.
  • for parents
  • Illiteracy
  • Presence of deafness, blindness or physical disability, when another family member cannot be responsible for the application of the protocol.

结局指标

主要结局

Difference between groups

时间窗: 6 moths

Early intervention prevents developmental delays in children with congenital heart disease.

次要结局

未报告次要终点

研究者

发起方
Instituto de Cardiologia do Rio Grande do Sul
申办方类型
Other
责任方
Sponsor

研究点 (2)

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