NCT01059708

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

January 28, 2010

Last Update Submit

March 15, 2011

Conditions

Carbon Monoxide Poisoning

Keywords

outcomes carbon monoxide poisoning children pediatric

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with cognitive sequelae at 6 weeks and 6 months following CO poisoning will be reported.

    6 weeks and 6 months after carbon monoxide poisoning incident.

Secondary Outcomes (3)

  • To determine which individual neurocognitive outcomes at 6 weeks and 6 months differ from normative data.

    6 weeks and 6 months after carbon monoxide poisoning incident.

  • To determine whether there is a difference in neurocognitive outcomes between measurement at 6 weeks and 6 months.

    6 weeks and 6 months after carbon monoxide poisoning incident.

  • To determine if there is a difference in the vestibular health of patients between measurements at 6 weeks and 6 months.

    6 weeks and 6 months after carbon monoxide poisoning incident.

Study Arms (1)

CO poisoned children

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

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children, ages 6-16, following CO poisoning

You may qualify if:

  • Age 6 through 16.
  • 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.
  • Willing to come to Salt Lake City or Provo for evaluation

You may not qualify if:

  • Prior history of neurological injury with permanent sequelae.
  • Prior history of chronic neurological disorder such as attention deficit disorder, learning disability, multiple sclerosis, cerebral palsy, demyelinating disease, meningitis with sequelae
  • Insulin dependent diabetes (due to the confound of possible brain microvascular disease and episodes of hypoglycemia)
  • Use of illicit drugs
  • Use of alcohol in excess
  • Pregnancy
  • Carbon monoxide poisoning from a suicide attempt or concomitant smoke inhalation
  • Subject or parent/guardian non-English-speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Healthcare, LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Carbon Monoxide Poisoning

Condition Hierarchy (Ancestors)

Gas PoisoningPoisoningChemically-Induced Disorders

Study Officials

  • Lindell K Weaver, MD

    Intermountain Healthcare, LDSH Hyperbaric Medicine

    STUDY DIRECTOR

  • Susan Churchill, APRN-NP

    Intermountain Healthcare, LDSH Hyperbaric Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2010

First Posted

February 1, 2010

Study Start

November 1, 2007

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations

US(1)