Carbon Monoxide PoisoningCO PEDNCT01059708
Outcome Following Carbon Monoxide Poisoning in Children
An observational study of Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Carbon Monoxide Poisoning
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children, ages 6-16, following CO poisoning
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Healthcare, LDS Hospital
Salt Lake City, Utah, 84143
About this study
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.
Read the 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:
- Which individual neurocognitive (thinking) outcomes at 6 weeks and 6 months differ from normative data.
- Whether there is a difference in neurocognitive (thinking) outcomes between measurement at 6 weeks and 6 months.
- If there is a difference in the vestibular (balance) health of patients between measurements at 6 weeks and 6 months.
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- outcomes carbon monoxide poisoning children pediatric
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CO poisoned children | Children, ages 6-16, who have been poisoned by carbon monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with cognitive sequelae at 6 weeks and 6 months following CO poisoning will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 weeks and 6 months after carbon monoxide poisoning incident.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startNov 2007
- Primary completionSep 2010
- Study completionDec 2010
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carbon Monoxide PoisoningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation
- Investigators
- Lindell K Weaver, MD, Study director, Intermountain Healthcare, LDSH Hyperbaric MedicineSusan Churchill, APRN-NP, Principal investigator, Intermountain Healthcare, LDSH Hyperbaric Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059708
- Sponsor's protocol ID
- 1004920
- Acronym
- CO PED
- Status last verified
- Mar 2011
- First submitted
- 28 Jan 2010
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Following Carbon Monoxide Poisoning in Children
- ClinicalTrials.gov ID
- NCT01059708
- Acronym / sponsor ID
- CO PED / 1004920
- Conditions
- Carbon Monoxide Poisoning
- Keywords
- outcomes carbon monoxide poisoning children pediatric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation
- Study start
- Nov 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which individual neurocognitive (thinking) outcomes at 6 weeks and 6 months differ from normative data.
- Whether there is a difference in neurocognitive (thinking) outcomes between measurement at 6 weeks and 6 months.
- If there is a difference in the vestibular (balance) health of patients between measurements at 6 weeks and 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CO poisoned children | – | –Children, ages 6-16, who have been poisoned by carbon monoxide |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children, ages 6-16, following CO poisoning
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindell K Weaver, MD study director
Intermountain Healthcare, LDSH Hyperbaric Medicine
Susan Churchill, APRN-NP principal investigator
Intermountain Healthcare, LDSH Hyperbaric Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carbon Monoxide Poisoning, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2011.