The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era

Condition(s) studied

Investigational drug(s) / intervention(s)

Therapeutic hypothermia: 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 for moderate or severe NE

Study summary

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:

1. Compare executive function, attention, social cognition, behaviour, anxiety, self-esteem, and peer problems between children with NE-TH and matched peers without NE.
2. Compare brain volumes, cortical and subcortical morphology, white matter microstructure, and myelination between children with NE-TH and matched peers without NE.
3. 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.

Eligibility

Primary outcome measure(s)

• Higher order cognitive abilities — 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).
• Psycho-emotional abilities — 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.
• Motor skills — 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.
• Functional profile — DAY 1
  Adaptive Behaviour Assessment Systems 3rd Ed.
• Brain profile — DAY 1
  Quantitative MRI measuring structural brain integrity

Trial sites (2)

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in Canada

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