Outcome Following Carbon Monoxide Poisoning in Children

NCT ID: NCT01059708

Last Updated: 2011-03-17

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

Brief Summary

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.

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.

Conditions

Carbon Monoxide Poisoning

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CO poisoned children

Children, ages 6-16, who have been poisoned by carbon monoxide

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deseret Foundation

OTHER

Sponsor Role: collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Intermountain Healthcare

Principal Investigators

Lindell K Weaver, MD

Role: STUDY_DIRECTOR

Intermountain Healthcare, LDSH Hyperbaric Medicine

Susan Churchill, APRN-NP

Role: PRINCIPAL_INVESTIGATOR

Intermountain Healthcare, LDSH Hyperbaric Medicine

Locations

Intermountain Healthcare, LDS Hospital

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

1004920

Identifier Type: -

Identifier Source: org_study_id