๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2023-10-19

The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era (NCT05756296)

The Long-term Consequences of Neonatal Encephalopathy in the Hypothermia Era: Protocol for a Follow-up Cohort Study at 9 Years of Age

๐ŸŸก Not Yet Recruiting Interventional Protocol ๐Ÿ“Š Observational Clinical Research Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Centre Hospitalier Universitaire Ste-Justine (CHUSJ). โ€” Montreal, Quebec

Age range: 8 Years to 11 Years

๐Ÿงช Interventions in This Study

  • Therapeutic hypothermia (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (2 Sites)

  • Centre Hospitalier Universitaire Ste-Justine (CHUSJ). โ€” Montreal, Quebec
  • the Montreal Children's Hospital (MCH) of the McGill University Health Centre โ€” Montreal, Quebec

๐Ÿ“ž Contact the Study Coordinator

Phone: (514) 934-1934

Email: marie.brossardracine@mcgill.ca

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—