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

NCT05756296 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 198

Last updated 2023-10-23

No results posted yet for this 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.

Conditions

  • Neonatal Encephalopathy
  • Therapeutic Hypothermia
  • Brain Injuries
  • Child Development

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Eligibility

Min Age
8 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05756296 on ClinicalTrials.gov