Status:
COMPLETED
Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Intellectual Disability
Perceptual Disorders
Eligibility:
All Genders
30-13 years
Brief Summary
The purpose of this study is to determine the relationships between sedative exposure during pediatric critical illness and long-term neurocognitive outcomes. We will test for drug- and dose-dependent...
Detailed Description
Ensuring the safety and comfort of the more than 100,000 critically ill infants and young children supported on mechanical ventilation in the US each year is integral to the practice of pediatric crit...
Eligibility Criteria
Inclusion
- RESTORE subjects
- Age ≤8 years and PCPC=1 at RESTORE PICU admission
- PCPC ≤3 at RESTORE hospital discharge Sibling control subjects
- Inclusion criteria:
- Age 4 to 17 years at time of testing
- PCPC=1
- Same biological parents as primary subject
- Lives with the primary subject
Exclusion
- RESTORE subjects
- Hospital readmission that includes MV and sedation
- History of cardiac arrest, traumatic brain injury (TBI) with loss of consciousness, genetic disorder, premature birth \<32 weeks gestational age, or birth weight \<2500 g Sibling control subjects
- Adopted or step siblings
- History of MV and sedation, receipt of general anesthesia, cardiac arrest, TBI with loss of consciousness, genetic disorder, premature birth \<32 weeks gestational age, or birth weight \<2500 gm.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02225041
Start Date
August 1 2014
End Date
December 1 2018
Last Update
June 18 2019
Active Locations (31)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
2
University Medical Center, The University of Arizona
Tucson, Arizona, United States, 85724
3
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609-1809
4
Children's Hospital of Orange County
Orange, California, United States, 92868