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NCT02225041 · ClinicalTrials.gov registry record

Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

A clinical trial of Intellectual Disability and Memory Disorders, sponsored by University of Pennsylvania.

Completed
Registry status
360
Enrollment target
20
Study locations

NCT02225041 is a study of Intellectual Disability and Memory Disorders that has completed, run by University of Pennsylvania. The registered enrollment target is 360 participants, roughly in line with the 340-participant average among 26 other Intellectual Disability trials with a reported enrollment target. The trial reports 20 study locations across 11 states.

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The verdict

NCT02225041, a study of Intellectual Disability and Memory Disorders, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
360 participants
Enrollment target
20
Study locations

Study 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.

Study Locations (20)

California

  • Children's Hospital and Research Center at Oakland - Oakland
  • Children's Hospital of Orange County - Orange
  • Lucile Salter Packard Children's Hospital at Stanford - Palo Alto
  • University of California Davis Medical Center - Sacramento
  • Children's Hospital at University of California San Francisco Medical Center - San Francisco

Connecticut

  • Connecticut Children's Medical Center - Hartford
  • Yale-New Haven Children's Hospital - New Haven

Florida

  • Holtz Children's Hospital - Miami
  • Florida Hospital for Children - Orlando

Illinois

  • Children's Memorial Hospital, Chicago - Chicago
  • Advocate Hope Children's Hospital - Oak Lawn

Maryland

  • University of Maryland Hospital for Children - Baltimore
  • Johns Hopkins Children's Center - Baltimore

Missouri

  • Children's Mercy Hospital, Kansas City - Kansas City
  • St. Louis Children's Hospital - St Louis

Alabama

  • Children's Hospital of Alabama - Birmingham

Arizona

  • University Medical Center, The University of Arizona - Tucson

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2014-08
Est. Completion 2018-12

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT02225041

The ClinicalTrials.gov registry entry for NCT02225041 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 340-participant average among 26 other Intellectual Disability trials with a reported enrollment target. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Intellectual Disability appearing as the primary indexed condition, and to 0 interventions.

NCT02225041 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Connecticut, Florida.

Frequently Asked Questions

What is clinical trial NCT02225041 about?

NCT02225041 is a clinical study titled "Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood". 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 s...

What is the current status of trial NCT02225041?

This trial is currently completed. The enrollment target is 360 participants. The study started on 2014-08. Estimated completion is 2018-12.

What conditions does trial NCT02225041 study?

This clinical trial studies the following conditions: Intellectual Disability, Memory Disorders, Perceptual Disorders.

Who is sponsoring clinical trial NCT02225041?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02225041 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.