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Sedation Strategy and Cognitive Outcome After Critical Illness in Early Childhood

NCT02225041 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 360

Last updated 2019-06-18

No results posted yet for this 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

  • Intellectual Disability
  • Perceptual Disorders
  • Memory Disorders

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Martha AQ Curley, RN, PhD · University of Pennsylvania

  • R. Scott Watson, MD · Seattle Childrens Hospital

Eligibility

Min Age
30 Months
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225041 on ClinicalTrials.gov