The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era
Key facts
- Where
- Montreal, CanadaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 11 years old?
Source: NCT05756296, who can take part
Where in Canada
- Centre Hospitalier Universitaire Ste-Justine (CHUSJ).Montreal, CanadaContact: Marie Brossard-Racine, PhDNo longer taking part
- the Montreal Children's Hospital (MCH) of the McGill University Health CentreMontreal, CanadaContact: Marie Brossard-Racine, PhDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Trial code
- NCT05756296
- Record updated
- 23 October 2023
- Original description
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:Read full original descriptionShow less
The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age
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.
Inclusion: 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.
Exclusion: any contraindication for MRI (e.g., metal implant, claustrophobia); Participants with a history of; congenital infections; genetic or metabolic disorders; major brain malformations (e.g., lissencephaly) and.