Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood
RESTORE-cog
1 other identifier
observational
360
1 country
31
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 relationships between sedative exposure and neurocognitive outcomes along the early developmental spectrum and will control for baseline and environmental factors, as well as the severity and course of illness. Hypotheses:
- 1.Greater exposure to benzodiazepines and/or ketamine will be associated with lower IQ even when controlling for severity of illness, hospital course, and baseline factors. In addition, benzodiazepines and/or ketamine will negatively affect other aspects of neurocognitive function.
- 2.Younger children exposed to benzodiazepines and/or ketamine will have worse neurocognitive outcomes than older children with similar sedative exposure and severity of illness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Longer than P75 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 18, 2019
June 1, 2019
4.3 years
July 25, 2014
June 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive function at 2.5 years post-ICU discharge, as assessed using standardized tests of attention, processing speed, learning and memory, visual-spatial skills, motor skills, language, executive function, IQ, and behavior
2.5 to 5 years post-discharge
Eligibility Criteria
RESTORE subjects who consented for 6-month follow-up with normal baseline cognitive function aged 2 weeks to 8 years at PICU admission. In addition, we will study matched, healthy siblings of these subjects to provide data on an unexposed group with similar baseline biological characteristics and environment. If more than one sibling meets enrollment criteria, the one closest in age will be selected.
You may qualify if:
- RESTORE subjects
- Age ≤8 years and PCPC=1 at RESTORE PICU admission
- PCPC ≤3 at RESTORE hospital discharge Sibling control subjects
- Age 4 to 17 years at time of testing
- PCPC=1
- Same biological parents as primary subject
- Lives with the primary subject
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
University Medical Center, The University of Arizona
Tucson, Arizona, 85724, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609-1809, United States
Children's Hospital of Orange County
Orange, California, 92868, United States
Lucile Salter Packard Children's Hospital at Stanford
Palo Alto, California, 94304-0126, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Children's Hospital at University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06520-8064, United States
Nemours/Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Holtz Children's Hospital
Miami, Florida, 33136, United States
Florida Hospital for Children
Orlando, Florida, 32803, United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614-3363, United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453, United States
University of Maryland Hospital for Children
Baltimore, Maryland, 21201-1595, United States
Johns Hopkins Children's Center
Baltimore, Maryland, 21287, United States
University of Massachusetts Memorial Children's Medical Center
Worcester, Massachusetts, 01655, United States
C. S. Mott Children's Hospital of the University of Michigan
Ann Arbor, Michigan, 48109-0243, United States
Children's Mercy Hospital, Kansas City
Kansas City, Missouri, 84108, United States
St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756-0001, United States
Cohen Children's Medical Center of New York
New Hyde Park, New York, 11040, United States
The Children's Hospital at Montefiore
The Bronx, New York, 10467, United States
Duke Children's Hospital and Health Center
Durham, North Carolina, 27710, United States
Doernbecher Children's Hospital
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Monroe Carell, Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232-9075, United States
Medical City Children's Hospital
Dallas, Texas, 75230, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Related Publications (1)
Curley MAQ, Watson RS, Cassidy AM, Burns C, Delinger RL, Angus DC, Asaro LA, Wypij D, Beers SR; RESTORE-cognition Study Investigators. Design and rationale of the "Sedation strategy and cognitive outcome after critical illness in early childhood" study. Contemp Clin Trials. 2018 Sep;72:8-15. doi: 10.1016/j.cct.2018.07.004. Epub 2018 Jul 11.
PMID: 30017814DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martha AQ Curley, RN, PhD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
R. Scott Watson, MD
Seattle Childrens Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2014
First Posted
August 25, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
June 18, 2019
Record last verified: 2019-06