CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 360 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02225041
NCT02225041N/ACompleted

Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

University of Pennsylvania·observational·Posted Aug 25, 2014·Updated Jun 18, 2019

In Brief

An observational study for Intellectual Disability and 2 related conditions. Completed, enrolled 360 participants across 31 sites.

Detailed 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 Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 25, 2014
Enrollment StartAug 1, 2014
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 11.9 years ago