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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-11
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre

About this trial

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 criteria

Qualifiers

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

Disqualifiers

congenital infections

genetic or metabolic disorders

major brain malformations (e.g., lissencephaly) and

any contraindication for MRI (e.g., metal implant, claustrophobia)

Trial design

Treatments tested in this trial

  • Therapeutic hypothermia

Treatment groups

198 Participants
are divided into 2 treatment groups

Sponsors and collaborators