Outcome Following Carbon Monoxide Poisoning in Children (CO PED)

This study has been terminated.
(Low enrollment.)
Sponsor:
Collaborator:
Deseret Foundation
Information provided by:
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01059708
First received: January 28, 2010
Last updated: March 15, 2011
Last verified: March 2011
  Purpose

Carbon monoxide poisoning is common. Many adults with CO poisoning have long-term, even permanent brain injury following poisoning. However, very little is known about the long-term outcome of children with carbon monoxide (CO) poisoning. In this study we plan to perform cognitive (thinking) and vestibular (balance) testing in children (ages 6 to 16)at 6 weeks and 6 months following CO poisoning.

At the 6-week visit, if the child and parents agree, we will ask each child to provide a DNA sample by one of three methods: mouthwash, spit collection, or swabbing the inside of the child's cheek. Each child's DNA will be analyzed for genes that are known to affect outcome following brain injury.


Condition
Carbon Monoxide Poisoning

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome Following Carbon Monoxide Poisoning in Children

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Percentage of patients with cognitive sequelae at 6 weeks and 6 months following CO poisoning will be reported. [ Time Frame: 6 weeks and 6 months after carbon monoxide poisoning incident. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine which individual neurocognitive outcomes at 6 weeks and 6 months differ from normative data. [ Time Frame: 6 weeks and 6 months after carbon monoxide poisoning incident. ] [ Designated as safety issue: No ]
  • To determine whether there is a difference in neurocognitive outcomes between measurement at 6 weeks and 6 months. [ Time Frame: 6 weeks and 6 months after carbon monoxide poisoning incident. ] [ Designated as safety issue: No ]
  • To determine if there is a difference in the vestibular health of patients between measurements at 6 weeks and 6 months. [ Time Frame: 6 weeks and 6 months after carbon monoxide poisoning incident. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA will be obtained by mouthwash, spit collection, or buccal swab,


Estimated Enrollment: 40
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
CO poisoned children
Children, ages 6-16, who have been poisoned by carbon monoxide

Detailed Description:

Each child's participation in this study is expected to last 6 months. Testing will be scheduled around 6 weeks after the carbon monoxide (CO) poisoning episode. During testing, each child will be asked to complete tests that measure cognitive (thinking), emotional, and behavioral performance. We will collect information from each child's medical record about the CO poisoning episode, and we will have a parent complete a questionnaire about any problems he or she may have observed in their child since the poisoning. The cognitive testing will take about 3.5 hours at the 6-week interval, and 2.5 hours at the 6-month interval.

Around the same time, each child will also be scheduled for vestibular (balance) testing at the Intermountain Hearing and Balance Center. Vestibular testing will occur twice, at 6-weeks and 6-months following poisoning.

At the 6-week visit, if the child and parents agree, we will ask each child to provide a DNA sample by one of three methods: mouthwash, spit collection, or swabbing the inside of the child's cheek. Each child's DNA will be analyzed for genes that are known to affect outcome following brain injury such as apolipoprotein E, and the sample will also be stored for an indefinite period of time. If discoveries are made about other genes that affect outcome following brain injury, each child's DNA will be analyzed for those genes as well.

The primary outcome measure will be the percentage of patients with cognitive sequelae (thinking complications or results) at 6 weeks and 6 months following CO poisoning.

Secondarily, we will also determine:

  1. Which individual neurocognitive (thinking) outcomes at 6 weeks and 6 months differ from normative data.
  2. Whether there is a difference in neurocognitive (thinking) outcomes between measurement at 6 weeks and 6 months.
  3. If there is a difference in the vestibular (balance) health of patients between measurements at 6 weeks and 6 months.
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children, ages 6-16, following CO poisoning

Criteria

Inclusion Criteria:

  1. Age 6 through 16.
  2. Acute carbon monoxide poisoning. Since we will be identifying potentially eligible patients using an electronic tool, the diagnosis of CO poisoning should be established by the evaluating physician. However, with the initial contact with the patients' parents, we will confirm the diagnosis, and only those patients with CO poisoning will be eligible.
  3. Willing to come to Salt Lake City or Provo for evaluation

Exclusion Criteria:

  1. Prior history of neurological injury with permanent sequelae.
  2. Prior history of chronic neurological disorder such as attention deficit disorder, learning disability, multiple sclerosis, cerebral palsy, demyelinating disease, meningitis with sequelae
  3. Insulin dependent diabetes (due to the confound of possible brain microvascular disease and episodes of hypoglycemia)
  4. Use of illicit drugs
  5. Use of alcohol in excess
  6. Pregnancy
  7. Carbon monoxide poisoning from a suicide attempt or concomitant smoke inhalation
  8. Subject or parent/guardian non-English-speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059708

Locations
United States, Utah
Intermountain Healthcare, LDS Hospital
Salt Lake City, Utah, United States, 84143
Sponsors and Collaborators
Intermountain Health Care, Inc.
Deseret Foundation
Investigators
Study Director: Lindell K Weaver, MD Intermountain Healthcare, LDSH Hyperbaric Medicine
Principal Investigator: Susan Churchill, APRN-NP Intermountain Healthcare, LDSH Hyperbaric Medicine
  More Information

No publications provided

Responsible Party: Susan K. Churchill, APRN-NP, Clinical Coordinator, Intermountain Healthcare
ClinicalTrials.gov Identifier: NCT01059708     History of Changes
Other Study ID Numbers: 1004920
Study First Received: January 28, 2010
Last Updated: March 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
outcomes carbon monoxide poisoning children pediatric

Additional relevant MeSH terms:
Carbon Monoxide Poisoning
Poisoning
Gas Poisoning
Substance-Related Disorders
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014