The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 198
- 试验地点
- 2
- 主要终点
- Brain profile
研究概览
简要总结
The goal of this study is to characterize the ability and related brain profiles of children with Neonatal encephalopathy (NE) - Therapeutic hypothermia (TH) at 9 years old. The main questions it aims to answer are:
- Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.
- Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.
- Evaluate the associations of perinatal risk factors and structural brain integrity with neuropsychological deficits to inform about the potential aggravating and protective factors for neuropsychological functioning.
Participants will complete one study visit to perform standardized evaluations and a brain MRI. Parents of participants will be invited to complete a series of questionnaires during this study visit or at a moment of their choice virtually.
详细描述
Rationale:
Therapeutic hypothermia (TH) became the standard of care treatment for neonates with moderate and severe neonatal encephalopathy (NE) in most industrialized countries about 10 years ago. Although TH is effective in reducing mortality and the incidence of severe developmental disabilities, various morbidities are still frequent in survivors. Moreover, because the focus of previous follow-up studies has been restricted to mortality rates and the most severe forms of morbidities, it is wrong to conclude that TH minimizes all developmental deficits. In fact, recent literature reports frequent cognitive and behavioural difficulties at school entry in children with NE-TH without severe disabilities. Although these difficulties can be less impressive than cerebral palsy and intellectual disability, their negative impacts on a child's self-determination and family well-being are not less important and their nature and extend need to be comprehensively assessed.
Aims and Hypotheses:
- To compare higher-order cognitive, socialization, and psycho-emotional abilities using comprehensive standardized assessments of outcomes between 9-year-old children with NE-TH and age- and sex-matched peers without NE.
Hypothesis 1: Children with NE-TH will display lower IQ, executive functioning, attention, social cognition, and self-esteem, but more anxiety and behavioural and peer problems than age- and sex-matched peers without NE-TH. 2. To compare structural brain integrity using quantitative MRI between 9-year-old children with NE-TH and age- and sex-matched peers without NE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •born between 2014 and 2018
- •received whole-body cooling to an esophageal temperature of 33.5°C initiated within the first 6 hours of life, continued for 72 hours, and then they were slowly rewarmed received TH for moderate or severe NE
排除标准
- •Participants with a history of
- •congenital infections
- •genetic or metabolic disorders
- •major brain malformations (e.g., lissencephaly) and
- •any contraindication for MRI (e.g., metal implant, claustrophobia)
结局指标
主要结局
Brain profile
时间窗: DAY 1
Quantitative MRI measuring structural brain integrity
Psycho-emotional abilities
时间窗: DAY 1
Self-esteem (Self-Concept Inventory from the Beck Youth Inventories-II), children's anxiety and emotional regulation (Spence Children's Anxiety Scale, the Multidimensional Anxiety Scale for Children, and the Difficulties in Emotion Regulation Scales). Predominance of profiles (e.g., predominantly affective, cognitive, or generalized) will be examined following an in-depth interpretation of the cognitive and psycho-emotional outcomes.
Functional profile
时间窗: DAY 1
Adaptive Behaviour Assessment Systems 3rd Ed.
Higher order cognitive abilities
时间窗: DAY 1
Estimated IQ (Wechsler Abbreviated Scale of Intelligence 2nd ed. \[WASI-2\]), inhibition (Stroop test), planning (Tower - Delis-Kaplan Executive Function System \[D-KEFS\] and Rey-Osterrieth Complex Figure), impulsivity (Conner Continuous Performance Test - 3rd Ed \[CPT-3\]), working memory (Digit span), and word retrieval (verbal fluency - D-KEFS). Specific attentional skills; immediate (Digit Span) and sustained attention (CPT-3). Visual memory (Rey-Osterrieth Complex Figure). To characterize the ability to understand that others have thoughts, ideas, and feelings, and how emotion relates to social context, as well as the ability to recognize affect (Theory of Mind and Affect Recognition subtests).
Motor skills
时间窗: DAY 1
Motor skills will be evaluated using the Movement Assessment Battery for Children-2nd Ed.in children without CP. In children with CP, motor skills will be evaluated with the Gross Motor Function Measure and subsequently be classified using the Gross Motor Function Classification System and the Manual Ability Classification System.Visual-motor integration will be assessed with the Berry-Buktenica Developmental Test of Visual-Motor Integration.
次要结局
未报告次要终点
研究者
Marie Brossard-Racine
Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre