Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

Completed

Conditions studied: Intellectual Disability, Perceptual Disorders, Memory Disorders

In brief

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.

Key facts

Study ID

NCT02225041

Run by

University of Pennsylvania

People needed

360

Starts

2014-08-01

Expected to finish

2018-12-01

Last updated by the study team

2019-06-18

Who can join

Age: 3 and older, up to 13. Sex: any. Healthy volunteers: accepted.

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
• Inclusion criteria:
• 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.

Where it is running

• Children's Hospital of Alabama — Birmingham, Alabama, United States
• University Medical Center, The University of Arizona — Tucson, Arizona, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Lucile Salter Packard Children's Hospital at Stanford — Palo Alto, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Children's Hospital at University of California San Francisco Medical Center — San Francisco, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale-New Haven Children's Hospital — New Haven, Connecticut, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Holtz Children's Hospital — Miami, Florida, United States
• Florida Hospital for Children — Orlando, Florida, United States
• Children's Memorial Hospital, Chicago — Chicago, Illinois, United States
• Advocate Hope Children's Hospital — Oak Lawn, Illinois, United States
• University of Maryland Hospital for Children — Baltimore, Maryland, United States
• Johns Hopkins Children's Center — Baltimore, Maryland, United States
• University of Massachusetts Memorial Children's Medical Center — Worcester, Massachusetts, United States
• C. S. Mott Children's Hospital of the University of Michigan — Ann Arbor, Michigan, United States
• Children's Mercy Hospital, Kansas City — Kansas City, Missouri, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• The Children's Hospital at Montefiore — The Bronx, New York, United States
• Duke Children's Hospital and Health Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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