Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 6
- 主要终点
- Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
研究概览
简要总结
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
详细描述
Congenital heart disease (CHD) is the leading cause of birth defects. Over 90% of children born with CHD reach adulthood. 50% of them will develop a neurodevelopmental disorder (NDD) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life.
In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment.
Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse (APN) during the usual cardiac follow-up. Children with CHD aged 1 to 5 will be included. If NDD is suspected, the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning. Patients with higher NDD risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation.
This study will investigate the feasibility and performance of an APN screening in this NDD-high risk 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
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital heart disease with stable status defined by last operation >3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion
- •Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life,
- •Patient aged 1 to 5 years.
- •No previous medical diagnosis of NDD
- •Parental or legal guardian's consent.
- •Social security affiliation (for France only)
排除标准
- •Patients with a genetic or poly-malformative syndrome with known neurological impairment.
- •Neurodevelopmental disorder already known/treated
- •Neurodevelopmental status evaluation within the last 6 months.
结局指标
主要结局
Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
时间窗: 4 months (to obtain the neurophysiologist assessment)
This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening.
次要结局
- Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))
- Prevalence of NDD in the high risk population(18 months)
- Feasibility of the IPA screening for NDD(18 months)
- Performance (sensibility) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))
- Performance (specificity) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))
- Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))