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Completed No phase listed Observational Accepts healthy volunteers

Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

ClinicalTrials.gov ID: NCT02225041

Public ClinicalTrials.gov record NCT02225041. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 11:51 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02225041
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
University of Pennsylvania
Other
Enrollment
360 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Months to 13 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2014
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018
Last update posted
Jun 17, 2019

2014 – 2018

United States locations

U.S. sites
31
U.S. states
20
U.S. cities
29
Facility City State ZIP Site status
Children's Hospital of Alabama Birmingham Alabama 35233
University Medical Center, The University of Arizona Tucson Arizona 85724
Children's Hospital and Research Center at Oakland Oakland California 94609-1809
Children's Hospital of Orange County Orange California 92868
Lucile Salter Packard Children's Hospital at Stanford Palo Alto California 94304-0126
University of California Davis Medical Center Sacramento California 95817
Children's Hospital at University of California San Francisco Medical Center San Francisco California 94143
Connecticut Children's Medical Center Hartford Connecticut 06106
Yale-New Haven Children's Hospital New Haven Connecticut 06520-8064
Nemours/Alfred I. duPont Hospital for Children Wilmington Delaware 19803
Holtz Children's Hospital Miami Florida 33136
Florida Hospital for Children Orlando Florida 32803
Children's Memorial Hospital, Chicago Chicago Illinois 60614-3363
Advocate Hope Children's Hospital Oak Lawn Illinois 60453
University of Maryland Hospital for Children Baltimore Maryland 21201-1595
Johns Hopkins Children's Center Baltimore Maryland 21287
University of Massachusetts Memorial Children's Medical Center Worcester Massachusetts 01655
C. S. Mott Children's Hospital of the University of Michigan Ann Arbor Michigan 48109-0243
Children's Mercy Hospital, Kansas City Kansas City Missouri 84108
St. Louis Children's Hospital St Louis Missouri 63110
University of Nebraska Medical Center Omaha Nebraska 68114
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756-0001
Cohen Children's Medical Center of New York New Hyde Park New York 11040
The Children's Hospital at Montefiore The Bronx New York 10467
Duke Children's Hospital and Health Center Durham North Carolina 27710
Doernbecher Children's Hospital Portland Oregon 97239
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104
Monroe Carell, Jr. Children's Hospital at Vanderbilt Nashville Tennessee 37232-9075
Medical City Children's Hospital Dallas Texas 75230
Children's Medical Center Dallas Dallas Texas 75235
Primary Children's Medical Center Salt Lake City Utah 84113

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02225041, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 17, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02225041 live on ClinicalTrials.gov.

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