Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood
NCT02225041 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2014-08 |
| Est. Completion | 2018-12 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02225041
The ClinicalTrials.gov registry entry for NCT02225041 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Intellectual Disability appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02225041 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Connecticut, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02225041?
This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.