MedTrace Logo

Feasibility Study for Neurodevelopment Follow-up Study in PICU

NCT03345628 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2020-02-21

No results posted yet for this study

Summary

There is a large and growing body of animal evidence demonstrating neuroapoptosis and neurodevelopmental abnormalities after exposure to anesthetic agents. This has prompted an FDA warning concerning use of anesthetics and sedatives in children under 3 years of age. There has been very little investigation of the neurodevelopment effects of prolonged sedation in previously healthy infants in Paediatric Intensive Care. This feasibility study will recruit previously healthy infants who required respiratory support with or without sedation at up to 1 year of age and assess neurodevelopmental outcomes at 6 years of age.

Conditions

Interventions

DRUG

Sedatives

sedated group received sedative drugs to tolerated intubation and ventilation

Sponsors & Collaborators

  • St. Justine's Hospital

    collaborator OTHER

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

    lead OTHER

Eligibility

Max Age
52 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03345628 on ClinicalTrials.gov